Complete list of CDSCO-approved drugs in India
Central Drugs Standard Control Organization (CDSCO), Government of India, has a mandate for approval of drugs to be manufactured and imported for sale in India. The drugs approved by CDSCO can only be further licensed by State Licensing Authorities to various manufacturers in India. CDSCO often publishes the list of approved drugs/ new drugs on its website but the updation of the drugs is year-wise and department-wise. Also, there are numerous lists that a manufacturer has to go through to find the status of the drug that he intends to manufacture. There is no single list available mentioning the complete list of CDSCO-approved drugs in India.
Looking at this scenario, we at FedleyHealthcare have taken this onus onto ourselves to compile and organize the list of approximately 5000 products. We are hereby publishing the complete list of new drugs in one place in an easy, searchable format. We are committed to updating this list as and when the list of new approved drugs is issued by CDSCO. This initiative has been taken after a successful and widely applauded list of banned drugs and a list of solubility of Active Pharmaceutical Ingredients has been published on our website.
Fedley Healthcare is a one-stop destination for all pharma regulatory services. In a short span of time, we have created a niche for ourselves as regulatory consultants with expertise in a wide array of regulatory activities. Our services include, but are not limited to, new drug approval, medical device registration and licensure, FDC approval, Cosmetics Licensure, GMP Layouts preparation, Auditing, Training, etc. With a 100% success record, Fedleyhealthcare boasts of a team that not only helps you with the filing process but also performs the complete technical and administrative review of the data submitted to us. This helps to reduce the concerns raised by the regulators and helps to expedite the approval process. The transparent and supportive approach has helped us win accolades among our clients.
Sr. No. - Name of the Product - Composition - Indication - Date of Approval
Drug Approval List
1. Pegaspargase
Composition: Each vial contains: Pegaspargase 3750 IU per vial
Indication: As a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia who are hypersensitive to L-Asparaginase.
Approval Date: 04.01.2018
2. Cefditoren Pivoxil dry powder for suspension 100mg/5ml(Additional Indication)
Composition: Each 5ml reconstituted suspension contains: Cefditoren Pivoxil equivalent to Cefditoren 100mg
Indication: For the treatment of mild to moderate infection, also in children (2 months to 12 years of age), which are caused by susceptible strains of the designated microorganisms in the condition listed below:· Acute Bacterial Exacerbation of Chronic Bronchitis· Community-Acquired pneumonia· Pharyngitis/Tonsillitis· Uncomplicated Skin and skin –structure infection
Approval Date: 30.03.2017
3. Tenofovir Alafenamide Hemifumarate Bulk Emtricitabine 200mg/200mg +Tenofovir Alafenamide 10/25 mg Tablets
Composition: Tenofovir Alafenamide Hemifumarate Bulk Emtricitabine 200mg/200mg +Tenofovir Alafenamide 10/25 mg Tablets
Indication: In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus type-1 (HIV-1) infection in adults and adolescents aged 12 years and older
Approval Date: 10.01.2018
4. Emtricitabine 200mg/200mg +Tenofovir Alafenamide 10/25 mg Tablets
Composition: Emtricitabine 200mg/200mg +Tenofovir Alafenamide 10/25 mg Tablets
Indication: In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infections in adults and adolescents aged 12 years and older.
Approval Date: 10.01.2018
5. Clofarabine Bulk & Injection 20 mg/20ml vial
Composition: Clofarabine Bulk & Injection 20 mg/20ml vial
Indication: For the treatment of patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. This indication is based on the response rate
Approval Date: 16.01.2018
6. Denaverine Hydrochloride Injection (Vet.)
Composition: Denaverine Hydrochloride Injection (Vet.)
Indication: cattle: Facilitation of parturition in heifers; activation of interrupted parturitions; insufficient opening of the soft birth canal; narrowness of the cervix of first and second degree after correction of uterine torsions; improvement of the conditions for foetotomy; regulation of labour contractions of the uterus. Dogs: Activation of Interrupted Parturition
Approval Date: 16.01.2018
7. Eltrombopag olamine tablets 12.5mg(Additional strength & indication)
Composition: Each film-coated tablet contains: Eltrombopag olamine equivalent to Eltrombopag olamine as free acid 12.5mg
Indication: 1. Chronic ITP: For Adults for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) Thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. It should not be used in an attempt to normalize platelet counts. For Paediatric patients aged 1 year and above: Thrombocytopenia in paediatric patients 1 year and older with immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy (lt should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. It should not be used in an attempt to normalize platelet counts).2. For the treatment of patients with chronic Hepatitis C virus (HCV) infection for the treatment of thrombocytopenia to: Enable the initiation of interferon based therapy, optimize interferon based therapy. With the condition: to be sold by retail on the prescription of a Hematologist only
Approval Date: 06.02.2018
8. Fipronil 6.1 % m/v + Permethrin 54.5% m/V spot on solution for Dog (Vet.)
Composition: Fipronil 6.1 % m/v + Permethrin 54.5% m/V spot on solution for Dog (Vet.)
Indication: In dogs, to be used against infestations with fleas and/or ticks when repellent (anti-feeding) activity is necessary against sand-flies and/or mosquitoes
Approval Date: 20.02.2018
9. Paziquantel 0.0065 g + Abamectin 0.00025 g tablets for cat (Vet)
Composition: Paziquantel 0.0065 g + Abamectin 0.00025 g tablets for cat (Vet)
Indication: In infestation of cats with endoparasites, tapeworms (teniae), flukes, roundworms (nematodes); with ectoparasites - lice, fleas, pasture ticks, notoedric mange (feline scabies), "walking" dandruff (cheyletiellosis), and other mange, and particularly in cases of complex endo and ectoparasitic invasion.
Approval Date: 20.02.2018
10. Cadexomer Iodine Bulk & Powder 100 % w/w (contain 0.9 % w/v Iodine) or Cadexomer Iodine Ointment 500 mg (contains 0.9% w/v iodine)
Composition: Cadexomer Iodine Bulk & Powder 100 % w/w (contain 0.9 % w/v Iodine) or Cadexomer Iodine Ointment 500 mg (contains 0.9% w/v iodine)
Indication: For the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, infected traumatic, and surgical wounds
Approval Date: 05.03.2018
11. Alectinib Capsules 150mg(Additional Indication)
Composition: Each hard gelatin capsule contains: Alectinib 150mg equivalent to Alectinib hydrochloride 161.3mg
Indication: First-line treatment of patients with Anaplastic Lymphoma Kinase (ALK) - positive locally advanced or metastatic non-small cell lung cancer (NSCLC).With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 05.03.2018
12. Each film-coated tablet contains: Dolutegravir sodium equivalent to Dolutegravir……………… 50mgLamivudine IP……………. 300 mg, Tenofovir Disoproxil Fumarate IP ……. 300 mg. to Tenofovir Disoproxil …… 245mg
Composition: Each film-coated tablet contains: Dolutegravir sodium equivalent to Dolutegravir……………… 50mgLamivudine IP……………. 300 mg, Tenofovir Disoproxil Fumarate IP ……. 300 mg. to Tenofovir Disoproxil …… 245mg
Indication: For the management of Human Immunodeficiency Virus (HIV) infections in adults weighing more than 40kg.
Approval Date: 08.03.2018
13. Methotrexate injection prefilled syringe 15mg/0.3ml, 20mg/0.4ml and 25mg/0.5ml(Additional strength & indication)
Composition: Each 0.3ml prefilled syringe contains: Methotrexate 15mgEach 0.4ml prefilled syringe contains: Methotrexate 20mgEach 0.5ml prefilled syringe contains: Methotrexate 25mg
Indication: It is indicated in the treatment of
1. Active rheumatoid arthritis in adult patients.
2. Polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drug (NSAIDs) has been inadequate.
3. Severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, PUVA, and retinoids, and severe psoriatic arthritis in adult patients.
4. Mild to moderate Crohn's disease, either alone or in combination with corticosteroids, in adult patients.
Approval Date: 09.03.2018
14. Each film-coated tablet contains: Abacavir Sulphate USP eq. to Abacavir……………….. 600 mg Dolutegravir Sodium eq. to Dolutegravir……………50mg Lamivudine USP……….300mg
Composition: Each film-coated tablet contains: Abacavir Sulphate USP eq. to Abacavir……………….. 600 mg Dolutegravir Sodium eq. to Dolutegravir……………50mgLamivudine USP……….300mg
Indication: For the treatment of Human Immunodeficiency Virus (HIV) infection in adults weighing more than 40kg.
Approval Date: 12.03.2018
15. Dalfampridine Bulk & Film-coated extended release tablet 10 mg
Composition: Dalfampridine Bulk & Film-coated extended-release tablet 10 mg
Indication: For treatment to improve walking in patients with Multiple Sclerosis (MS)
Approval Date: 12.03.2018
16. Ulipristal Acetate 5 mg tablets
Composition: Ulipristal Acetate 5 mg tablets
Indication: For the pro-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age and intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age
Approval Date: 14.03.2018
17. Sildenafil powder for oral suspension 10mg/ml(Additional dosage form)
Composition: Each ml of reconstituted suspension contains: Sildenafil citrate equivalent to 10mg, Sodium benzoate 4.375mg
Indication: Adults: Treatment of adult patients with pulmonary arterial hypertension classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Pediatric population: Treatment of pediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary hemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease. With the condition: to be sold by retail on the prescription of a cardiologist only.
Approval Date: 20.03.2018
18. Fulvestrant 250mg/5ml injection(Additional Indication)
Composition: Each 5ml pre-filled syringe contains: Fulvestrant 250mg ethanol (96%)-10% w/v
Indication: For the treatment of estrogen receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy. With the condition: to be sold by retail on the prescription of an oncologist only.
Approval Date: 20.03.2018
19. Each ml cutaneous solution contains: Chlorhexidine gluconate solution IP Eq. to Chlorhexidine gluconate ……. 20 mg Isopropyl Alcohol IP …………… 0.70 ml
Composition: Each ml cutaneous solution contains: Chlorhexidine gluconate solution IP Eq. to Chlorhexidine gluconate ……. 20 mgIsopropyl Alcohol IP …………… 0.70 ml
Indication: For disinfectant of the skin before invasive medical procedures and maintenance of device insertion sites.
Approval Date: 22.03.2018
20. Bendamustine hydrochloride injection 90mg/ml(0.5ml vial & 2.0 ml vial)(Additional Indication)
Composition: Each ml contains: Bendamustine hydrochloride 90mg, ethanol 4.33% w/v
Indication: Frontline treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have clinical neuropathy at the time of diagnosis precluding the use of thalidomide or bortezomib-containing treatment.With the condition: to be sold by retail on the prescription of an Oncologist/Specialist only.
Approval Date: 23.03.2018
21. Each film coated tablet contains:Canagliflozin + Metformin HCL(50mg+500mg, 50mg+850mg, 50mg+1000mg, 150mg+500mg, 150mg+850mg, 150mg+ 1000mg) .
Composition: Each film coated tablet contains:Canagliflozin + Metformin HCL(50mg+500mg, 50mg+850mg, 50mg+1000mg, 150mg+500mg, 150mg+850mg, 150mg+ 1000mg)
Indication: Indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Canagliflozin and metformin is appropriate.Limitation of use: Not for treatment of type 1 diabetes or diabetic ketoacidosis.
Approval Date: 27.03.2018
22. Ulipristal Acetate bulk
Composition: Ulipristal Acetate bulk
Indication: -
Approval Date: 02.04.2018
23. Dydrogesterone tablet 10mg(Additional Indication)
Composition: Each film-coated tablet contains: Dydrogesterone 10mg
Indication: Luteal support as part of an Assisted Reproductive Technology (ART) treatment.With the condition: to be sold by retail on the prescription of a Gynecologist only
Approval Date: 06.04.2018
24. Febuxostat tablet 60mg & 20mg(Additional Strength)
Composition: Each film-coated tablet contains: Febuxostat 60mg & 20mg
Indication: For the treatment of chronic hyperuricemia in conditions where urate deposition has already occurred (including a history or presence of tophus and/or gouty arthritis)
Approval Date: 06.04.2018
25. Posaconazole injection 300mg/16.7ml (18mg/ml)(Additional Strength & Dosage Form)
Composition: Each injection contains: Posaconazole 300mg/16.7ml
Indication: For prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.With the condition: to be sold by retail on the prescription of a specialist only.
Approval Date: 13.04.2018
26. Riociguat bulk & 0.5mg/1.0mg/1.5mg/2.0mg/2.5 mg tablet
Composition: Riociguat bulk & 0.5mg/1.0mg/1.5mg/2.0mg/2.5 mg tablet
Indication: For the treatment of persistent/ recurrent chronic Thromoembolic pulmonary Hypertension (CTEPH) WHO Group 4) After surgical treatment or inoperable CTEPH to improve exercise capacity and WHO function
Approval Date: 16.04.2018
27. Each mL contains: i) Bupivacaine Hydrochloride IP 1.25mg Eq to anhydrous Bupivacaine Hydrochloride 1.185mgFentanyl Citrate IP Eq to Fentanyl 2.0 mcg Injection ii) Bupivacaine Hydrochloride IP 1.0mg Eq to anhydrous Bupivacaine Hydrochloride 0.948mgFentanyl Citrate IP Eq to Fentanyl 2.0 mcg Injection
Composition: Each ml contains: i) Bupivacaine Hydrochloride IP 1.25mg Eq to anhydrous Bupivacaine Hydrochloride 1.185mgFentanyl Citrate IP Eq to Fentanyl 2.0 mcg Injection ii) Bupivacaine Hydrochloride IP 1.0mg Eq to anhydrous Bupivacaine Hydrochloride 0.948mgFentanyl Citrate IP Eq to Fentanyl 2.0 mcg Injection
Indication: For maintaining the analgesia postoperatively. For maintaining analgesia during labour
Approval Date: 17.04.2018
28. Baricitinib 2mg/4mg film coated Tablets
Composition: Baricitinib 2mg/4mg film coated Tablets
Indication: For the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate
Approval Date: 07.05.2018
29. Teriflunomide tablet 7mg(Add. Lower strength)
Composition: Each film-coated tablet contains: Teriflunomide 7mg
Indication: For the treatment of patients with the relapsing form of multiple sclerosis. With the condition: to be sold by retail on the prescription of a neurologist only.
Approval Date: 07.05.2018
30. Apremilast film-coated tablet 10/20/30mg(Additional Indication)
Composition: Each film-coated tablet contains: Apremilast-10mg, 20mg,30mg
Indication: For the treatment of adult patients with Active psoriatic Arthritis.
Approval Date: 07.05.2018
31. Aripiprazole tablet 2mg(additional strength)
Composition: Each uncoated tablet contains: Aripiprazole-2mg
Indication: For the treatment of Schizophrenia in adolescent patients (13 to 17 years of age). With the condition: to be sold by retail on the prescription of a psychiatrist only.
Approval Date: 11.05.2018
32. Dextromethorphan HBr Lozenges 10mg(Add. dosage form & strength)
Composition: Each lozenge contains: Dextromethorphan HBr-33.33% Complex 30mg eq. to Dextromethorphan HBr 10mg
Indication: Cough suppressant for the relief of acute non-productive (dry, tickly) cough associated with respiratory tract infection in adult patients only.
Approval Date: 11.05.2018
33. Voglibose Orally Disintegrating Strips 0.2mg(Modified dosage form)
Composition: Each Orally Disintegrating Strip contains: Voglibose 0.2mg & 0.3mg
Indication: For improvement of parandial hyperglycemia in diabetes mellitus, when only diet and/or exercise or oral hypoglycaemic drugs, or insulin preparation in addition to diet and/or exercise do not result in adequate glycemic control.
Approval Date: 11.05.2018
34. Vortioxetine Hydrochloride 5 mg/10mg/15mg/20mg
Composition: Vortioxetine Hydrochloride 5 mg/10mg/15mg/20mg
Indication: for the treatment of major depressive disorder in adults
Approval Date: 14.05.2018
35. Tranexamic acid tablet 1000mg(Additional strength)
Composition: Each film-coated tablet contains: Tranexamic acid-1000mg.
Indication: For the treatment of menorrhagia
Approval Date: 21.05.2018
36. Eltrombopag Olamine Tablet 75mg(Additional strength)
Composition: Each film-coated tablet contains: Eltrombopag Olamine as free acid-75mg
Indication:
1. For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. It should not be used in an attempt to normalize platelet counts.
2. Indicated in patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia to: interferon-baseda. Enable the initiation of interferon-based therapy.b. Optimize interferon-based therapy.
3. For the treatment of patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy. For the treatment of thrombocytopenia in pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. (It should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. It should not be used in an attempt to normalize platelet counts. With the condition: to be sold by retail on the prescription of a hematologist only.
Approval Date: 29.05.2018
37. Thyroxine Sodium Tablet 37.5 mcg(Additional strength)
Composition: Each uncoated tablet contains: Thyroxine Sodium eq. to Anhydrous Thyroxine Sodium. 37.5 mcg.
Indication:
1. As replacement or supplemental therapy in patients of any age or state (including pregnancy) with hypothyroidism of any etiology except transient hypothyroidism during the recovery phase of sub-acute thyroiditis resultng from thyroid dysfunction, primary atrophy or partial or total absence of the thyroid gland or from the effects of surgery, radiation or drugs with or without the presence of goiter, including sub-clinical hypothyroidism; secondary (pituitary) hypothyroidism and tertiary (hypothalamic) hypothyroidism.
2. As a pituitary TSH suppressant in the treatment or prevention of various types of euthyroid goitres, including thyroid nodules, sub-acute or chronic lymphocytic thyroiditis (Hashimoto's), multi-nodular goitre, and in conjunction with surgery and radioactive iodine therapy in the management of thyrotropin-dependent well-differentiated papillary or follicular carcinoma of the thyroid.
Approval Date: 08.06.2018
38. Dabrafenib Hard Gelatin Capsule 50mg,& 75mg(Additional indication)
Composition: Each Hard Gelatin Capsule contains: Dabrafenib Mesylate eq. to Dabrafenib 50mg & 75mg
Indication: Dabrafenib in combination with Trametinib for the treatment of adult patients with advanced non-small cell lung cancer with BRAF V600 mutation. With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 08.06.2018
39. Trametinib Tablet 0.5mg & 2mg(Additional indication)
Composition: Each Film-coated tablet contains: Trametinib 0.5mg & 2mg
Indication: Trametinib in combination with Dabrafenib for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation. With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 08.06.2018
40. Vardenafil Hydrochloride Trihydrate Bulk and 2.5mg/5mg/10 mg/20 mg tablets
Composition: Vardenafil Hydrochloride Trihydrate Bulk and 2.5mg/5mg/10 mg/20 mg tablets
Indication: Treatment of erectile dysfunction in adult men
Approval Date: 11.06.2018
41. Trientine Hydrochloride Bulk and 250 mg capsule
Composition: Trientine Hydrochloride Bulk and 250 mg capsule
Indication: For the treatment of Wilson's disease (hepatolenticular degeneration) in patients intolerant to Penicillamine. It should be used when continued treatment with Penicillamine is no longer possible because of intolerable or life-endangering side effects.
Approval Date: 11.06.2018
42. Each film-coated tablet contains: Daclatasvir Dihydrochloride Eq to Daclatasvir………..60 mgSofosbuvir……………....400 mg
Composition: Each film-coated tablet contains: Daclatasvir Dihydrochloride Eq to Daclatasvir………..60 mg, Sofosbuvir……………....400 mg
Indication: For the treatment of patients with chronic Hepatitis C virus (HCV) genotype 3 infection
Approval Date: 12.06.2018
43. Azacitidine for injection 50mg/vial(Additional strength)
Composition: Each vial contains: Azacitidine….... 50mg Lyophilized powder for injection(for Subcutaneous or Intravenous use)
Indication: For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome.With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 22.06.2018
44. Nilotinib Capsules 50mg(Additional strength & add. indication)
Composition: Each Capsule contains: Nilotinib 50mg
Indication:
Pediatric1. Pediatric patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (CML) in the chronic phase.
2. Pediatric, patients with chronic phase Philadelphia Chromosome Positive (CML) with resistance or intolerance to prior therapy, including imatinib. With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 22.06.2018
45. Gadoteridol injection
Composition: Gadoteridol injection
Indication: To visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients over 2 years of age, lesions in the head and neck in adults.
Approval Date: 25.06.2018
46. Fipronil 50mg/134 mg/268mg/402mg spot on solution for cats and dogs
Composition: Fipronil 50mg/134 mg/268mg/402mg spot on solution for cats and dogs
Indication: For treatment of flea and tick infestation in cats and dogs (for veterinary use only)
Approval Date: 25.06.2018
47. FDC of Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg tablets
Composition: FDC of Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg tablets
Indication: In combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight of at least 35 kg) infected with Human Immunodeficiency Virus type-1 (HIV-1)
Approval Date: 25.06.2018
48. Each vial contains: Meropenem IP eq. to Anhydrous Meropenem……..1gmSodium Carbonate IP Eq. to Sodium……90.2 mg Sulbactam Sodium USP Eq. to Sulbactam………1gm Injection
Composition: Each vial contains: Meropenem IP eq. to Anhydrous Meropenem…….. 1 g Sodium Carbonate IP Eq. to Sodium……90.2 mgSulbactum Sodium USP Eq. to Sulbactum……… 1 g Injection
Indication: For the treatment of lower respiratory tract infection caused by gram-negative bacteria in adults only.
Approval Date: 25.06.2018
49. Imidacloprid and Flumethrin) Each 38 cm Seresto Collar Contains:(For Cats less than or equal to 8 Kg of body weight)Imidacloprid…..1.25gFlumethrin….0.56gii) Each 38 cm Seresto Collar Contains:(For Dogs less than or equal to 8 Kg of body weight)Imidacloprid…..1.25gFlumethrin….0.56giii) Each 38 cm Seresto Collar Contains:(For Dogs more than or equal to 8 Kg of body weight)Imidacloprid…..4.5gFlumethrin….2.03g
Composition: Imidacloprid and Flumethrin) Each 38 cm Seresto Collar Contains:(For Cats less than or equal to 8 Kg of body weight)Imidacloprid…..1.25gFlumethrin….0.56gii) Each 38 cm Seresto Collar Contains:(For Dogs less than or equal to 8 Kg of body weight)Imidacloprid…..1.25gFlumethrin….0.56giii) Each 38 cm Seresto Collar Contains:(For Dogs more than or equal to 8 Kg of body weight)Imidacloprid…..4.5gFlumethrin….2.03g
Indication: For the treatment and prevention against fleas, Ticks & Lice and For reducing the risk of Vector-Borne Disease transmission.
Approval Date: 26.06.2018
50. Each Film-coated tablet contains: Azilsartan Kamedoxomil eq to Azilsartan Medoxomil + Chlorthalidone IP(40mg+25mg,40mg + 12.5mg)
Composition: Each Film-coated tablet contains: Azilsartan Kamedoxomil eq to Azilsartan Medoxomil + Chlorthalidone IP (40mg+25mg,40mg + 12.5mg)
Indication: For the treatment of mild to moderate hypertension
Approval Date: 09.07.20
51. FDC of Azilsartan + chlorthalidone (40 mg + 12.5 mg)andAzilsartan + chlorthalidone (40 mg + 25 mg) tablet
Composition: FDC of Azilsartan + chlorthalidone (40 mg + 12.5 mg)andAzilsartan + chlorthalidone (40 mg + 25 mg) tablet
Indication: For the treatment of mild to moderate hypertension in adults
Approval Date: 09.07.2018
52. Fulvestrant 250mg/5ml injection(Additional indication)(for IM use only)
Composition: Each 5ml pre-filled syringe contains: Fulvestrant USP 250mg Ethanol (96%) BP-10% w/v
Indication: In combination with Palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 13.07.2018
53. Ganciclovir Sodium powder for Infusion 500mg(Additional indication)(for IV use only)
Composition: Each vial contains: Ganciclovir 500mg(In the form of the sodium salt)
Indication: For the treatment of cytomegalovirus (CMV) disease in immunocompromised individuals and for the prevention of CMV disease in patients with drug-induced immunosuppression following organ transplantation or cancer chemotherapy. With the condition: to be sold by retail on the prescription of a Specialist only.
Approval Date: 13.07.2018
54. Nepafenac Ophthalmic Suspension 0.3%w/v(Additional strength)
Composition: Each ml contains: Nepafenac 3.0mg
Indication: For the treatment of pain and inflammation associated with cataract surgery. With the condition: to be sold by retail on the prescription of an ophthalmologist only.
Approval Date: 13.07.2018
55. Tadalafil Orally Disintegrating Strip 5mg(Additional strength)
Composition: Each Orally Disintegrating Strip contains: Tadalafil 5mg
Indication: For the treatment of Erectile Dysfunction
Approval Date: 13.07.2018
56. Each capsule contains: Glycopyrronium (As Glycopyrrolate USP)…… 25mcgFormoterol Fumarate Dihydrate IP Eq. to Formoterol Fumarate……….6mcg(Capsule for inhalation)
Composition: Each capsules contains: Glycopyrronium (As Glycopyrrolate USP)…… 25mcgFormoterol Fumarate Dihydrate IP Eq. to Formoterol Fumarate……….6mcg
Indication: For the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema
Approval Date: 16.07.2018
57. For the treatment of Erectile Dysfunction(Additional indication)
Composition: Each film-coated tablet contains: Delamanid …..... 50mg
Indication: In exceptional cases and after a careful benefit/risk assessment, Delamanid treatment can be initiated in children >6 years of age, for use as part of an appropriate combination regimen for pulmonary multi-drug resistant tuberculosis (MDR-TB) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. With the condition: For the use in the Revised National Tuberculosis Control Program (RNTCP).
Approval Date: 27.07.2018
58. Osimertinib Film-coated tablet 40mg and 80mg(Additional indication)
Composition: Each film-coated tablet contains: Osimertinib 40mg, 80mg
Indication: As first-line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumours have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions mutations.With the condition: To be sold by retail on the prescription of an oncologist only.
Approval Date: 03.08.2018
59. FDC of Ceftolozane (1.0 gm) and Tazobactum (0.5 gm) injection
Composition: FDC of Ceftolozane (1.0 gm) and Tazobactum (0.5 gm) injection
Indication: Indicated for the treatment of patients 18 years or older with the following infections caused by designated susceptible microorganisms: • Complicated intra-abdominal infections (cIAI) caused by the following Gram-negative and Gram-positive microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius in combination with metronidazole in the ICU setting only. • Complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa in the ICU setting only.
Approval Date: 06.08.2018
60. Olaparib film-coated tablets (100mg, 150 mg)
Composition: Olaparib film-coated tablets (100mg, 150 mg)
Indication: Ovarian cancer:• For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. • For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.Breast cancer:• In patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment.
Approval Date: 13.08.2018
61. Nicotine Polacrilex Orally disintegrating strips 2mg & 4mg(New dosage form)
Composition: Each orally disintegrating strip contains: Nicotine Polacrilex eq. to Nicotine 2mg, 4mg
Indication: To reduce the withdrawal symptoms, including nicotine craving, associated with quitting smoking and quitting chewed tobacco and gutkha containing tobacco
Approval Date: 17.08.2018
62. Each combikit contains: Part A: One film-coated tablet of Atazanavir Sulphate and Ritonavir tablet. Each film-coated tablet contains: Atazanavir Sulphate IP eq. to Atazanavir..................................... 300mgRitonavir IP… ............................... 100 mg. Part B: One film-coated tablet of Abacavir Sulphate and Lamivudine tablet. Each film-coated tablet contains: Abacavir Sulphate IP eq to Abacavir............................................ 600mgLamivudine IP… ............................... 300mg
Composition: Each combikit contains: Part A: One film-coated tablet of Atazanavir Sulphate and Ritonavir tablet. Each film-coated tablet contains: Atazanavir Sulphate IP eq. to Atazanavir..................................... 300mgRitonavir IP… ............................... 100mgPart B: One film-coated tablet of Abacavir Sulphate and Lamivudine tablet. Each film-coated tablet contains: Abacavir Sulphate IP eq to Abacavir............................................ 600mgLamivudine IP… ............................... 300mg
Indication: For the management of Human Immunodeficiency Virus (HIV) infections
Approval Date: 17.08.2018
63. Each sachet contains:( Granules in sachet)Lopinavir IP………..40mgRitonavir IP………..10mg(Additional Dosage Form)
Composition: Each sachet contains:( Granules in sachet)Lopinavir IP………..40mgRitonavir IP………..10mg(Additional Dosage Form)
Indication: Combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (14 days and older)
Approval Date: 21.08.2018
64. Ethyl esters of Iodidzed fatty acids of Poppy Seed Oil solution for injection(Lipodol Ultra Fluid 10ml)(Additional Indication)
Composition: Each ampoule (10ml) contains: Ethyl esters of Iodidzed fatty acids of Poppy Seed Oil. Iodine content 48%, i.e. 480mg iodine per ml
Indication: Conventional Trans-Arterial Chemo-Embolization (cTACE) of Hepatocellular Carcinoma (HCC) in adults.
Approval Date: 06.09.2018
65. Methylcobalamin nasal spray 250mcg/spray(New Dosage form)
Composition: Each 0.1ml contains:Methylcobalamin 500mcgBenzalkonium chloride (As preservative) 0.02% w/v
Indication: Treatment of Vitamin B12 deficiency in patients without having neurological involvement.
Approval Date: 28.09.2018
66. Apomorphine Hydrochloride injection 10mg/ml (2ml and 5ml Ampoule)(subcutaneous use only)(Add. Dosage form and add. indication)
Composition: Each ml contains: Apomorphine hydrochloride 10mg
Indication: Treatment of disabling motor fluctuations (“on-off” phenomena) in patients with Parkinson’s disease, which persist despite individually titrated treatment with levodopa (with a peripheral decarboxylase inhibitor) and/or other dopamine agonists.With the condition: to be sold by retail on the prescription of a neurologist only
Approval Date: 28.09.2018
67. Carfilzomib for Injection 30mg/vial (Lyophilized injection)(Additional Strength)
Composition: Each vial contains: Carfilzomib 30mg
Indication: · Carfilzomib for injection is indicated in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.· Carfilzomib for injection is indicated as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 28.09.2018
68. Ceftazidime 2gm/Avibactam 0.5 gm powder for concentrate for solution for infusion
Composition: Ceftazidime 2gm/Avibactam 0.5 gm powder for concentrate for solution for infusion
Indication: Complicated Intra-abdominal infections (cIAI), Complicated Urinary tract infections (cUTI), including pyelonephritis, Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP) with susceptible gram-negative microorganisms
Approval Date: 01.10.2018
69. Each film coated tablet contains:Dapagliflozin…………5mgMetformin HCL ……. 1000mg(Immediate Release)
Composition: Each film coated tablet contains:Dapagliflozin…………5mgMetformin HCL ……. 1000mg(Immediate Release)
Indication: It is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both Dapagliflozin and Metformin is appropriate.
Approval Date: 03.10.2018
70. Each film coated tablet contains:1. Carvedilol 6.25mg + Ivabradine hydrochloride 5.390mg eq. to Ivabradine 5mg2. Carvedilol 6.25mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg3. Carvedilol 12.5mg + Ivabradine hydrochloride 5.390mg eq. to Ivabradine 5mg4. Carvedilol 12.5mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg5. Carvedilol 25mg + Ivabradine hydrochloride Ivabradine 5.390mg eq. to 5mg6. Carvedilol 25mg + Ivabradine hydrochloride 8.085 mg eq. to Ivabradine 7.5mg.
Composition: Each film-coated tablet contains:1. Carvedilol 6.25mg + Ivabradine hydrochloride 5.390mg eq. to Ivabradine 5mg2. Carvedilol 6.25mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg3. Carvedilol 12.5mg + Ivabradine hydrochloride 5.390mg eq. to Ivabradine 5mg4. Carvedilol 12.5mg + Ivabradine hydrochloride 8.085mg eq. to Ivabradine 7.5mg5. Carvedilol 25mg + Ivabradine hydrochloride Ivabradine 5.390mg eq. to 5mg6. Carvedilol 25mg + Ivabradine hydrochloride 8.085 mg eq. to Ivabradine 7.5mg.
Indication: It is indicated for as substituted therapy in adult patients with normal sinus rhythm already controlled by Ivabradine and carvedilol taken concomitantly at the same dose level for: i. The symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients. The treatment of chronic heart failure (II-IV NYHA-Class) with systolic dysfunction.
Approval Date: 03.10.2018
71. Sodium Alginate IP 250mg + Sodium Bicarbonate IP 133.5mg + Calcium Carbonate IP 80mg per 5ml oral liquid.
Composition: Sodium Alginate IP 250mg + Sodium Bicarbonate IP 133.5mg + Calcium Carbonate IP 80mg per 5ml oral liquid.
Indication: Indicated for the treatment of heartburn and indigestion.
Approval Date: 04.10.2018
72. Each film-coated tablet contains: Memantine Hydrochloride USP…. 10 mg, Donepezil Hydrochloride IP…….. 10mg(Additional Strength)
Composition: Each film-coated tablet contains: Memantine Hydrochloride USP…. 10 mg, Donepezil Hydrochloride IP…….. 10mg(Additional Strength)
Indication: For the treatment of moderate to severe Alzheimer’s disease.
Approval Date: 16.10.2018
73. Each film-coated tablet contains: Piperaquine Tetraphosphate as Piperaquine Tetraphosphate Tetrahydrate (QP)….160mgDihydroartemisinin (DHA) .... 20mg(Additional Strength)
Composition: Each film-coated tablet contains: Piperaquine Tetraphosphate as Piperaquine Tetraphosphate Tetrahydrate (QP)...160mgDihydroartemisinin (DHA) .... 20mg
Indication: For the treatment of uncomplicated Plasmodium Falciparum Malaria in pediatric and adolescent patients.
Approval Date: 16.10.2018
74. Each uncoated tablet contains: Calcium Citrate US ...............1200mgeq. to elemental Calcium.........252mgCalcitriol IP.............................0.25mcg(Additional indication)
Composition: Each uncoated tablet contains: Calcium Citrate US ...............1200mgeq. to elemental Calcium.........252mgCalcitriol IP.............................0.25mcg(Additional indication)
Indication: It is indicated for:-
1. Treatment of Hypocalcemia / Calcium & Phosphate abnormalities in patients with Uremic Osteodystrophy, Hypoparathyroidism & in hypophosphatemic rickets/osteomalacia.
2. Pre-dialysis Patients- management of secondary hyperparathyroidism and resultant metabolic bone disease in patients with moderate to severe chronic renal failure (CCr 15 to 55 mL/min) not yet on dialysis.
3. Dialysis Patients- management of hypocalcemia and the resultant metabolic bone disease in patients undergoing chronic renal dialysis.
4. Prevention of corticosteroid-induced osteoporosis in patients with renal impairment commencing oral steroid therapy at a dose and regimen expected to result in a significant bone loss.
5. Established osteoporosis / Post Menopausal Osteoporosis diagnosed by objective measuring techniques, such as densitometry, or by radiographic evidence of a traumatic fracture in patients with renal impairment.
Approval Date: 16.10.2018
75. Nilotinib hard Capsules 150mg & 200mg (Additional indication)
Composition: Each Capsule contains: Nilotinib 150mg & 200mg
Indication:
1. Treatment of Pediatric patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (CML) in the chronic phase.
2. Treatment of Paediatric patients with chronic phase Philadelphia Chromosome Positive (CML) with resistance or intolerance to prior therapy, including imatinib.
With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 18.10.2018
76. Dasatinib film-coated tablet 20mg, 50mg, 70mg and 100mg (Additional indication)
Composition: Each film-coated tablet contains: Dasatinib 20mg, 50mg, 70mg and 100mg
Indication: Treatment of Paediatric patients with Philadelphia Chromosome Positive Chronic myeloid leukemia (Ph+ CML) in chronic phase. With the condition: to be sold by retail on the prescription of an oncologist only.
Approval Date: 18.10.2018
77. Nifedipine Extended Release Tablet 60mg (Add. strength and indication)
Composition: Each extended-release film-coated tablet contains: Nifedipine 60mg
Indication: Vasospastic Angina,· Chronic stable Angina (Classical effort-Associated Angina),· Hypertension.With the condition: to be sold by retail on the prescription of a cardiologist only.
Approval Date: 18.10.2018
78. Evogliptin Tartrate Bulk and Tablets 5 mg
Composition: Evogliptin Tartrate Bulk and Tablets 5 mg
Indication: For treatment of type-2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control, when used as a monotherapy or in combination with Metformin
Approval Date: 22.10.2018
79. Lorcaserin Hydrochloride Bulk and 10 mg tablets
Composition: Lorcaserin Hydrochloride Bulk and 10 mg tablets
Indication: An adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes)
Approval Date: 22.10.2018
80. Levetiracetam injection 500mg/100ml, 1000 mg/100ml, and 1500mg/100ml. (Infusion bottle) (Additional dosage form)
Composition: Each 100 ml Infusion bottle contains: Levetiracetam in 0.82% sodium chloride (500mg/100ml), Levetiracetam in 0.75% sodium chloride (1000mg/100ml), Levetiracetam in 0.54% sodium chloride (1500mg/100ml)
Indication: As adjunctive therapy in adults (16 years and older) with the following types of seizures when oral administration is temporarily not feasible.· Partial onset seizures,· Myoclonic seizures in patients with juvenile myoclonic epilepsy,· Primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy. With the condition: to be sold by retail on the prescription of a neurologist only.
Approval Date: 27.10.2018
81. Each film-coated tablet contains: Ethinylestradiol IP................. 30 mcg, Dienogest IP………………..2mg
Composition: Each film-coated tablet contains: Ethinylestradiol IP.................30mcgDienogest IP………………..2mg
Indication: Indicated for use as an oral contraceptive and in the treatment of mild to moderate acne in women who seek oral contraception
Approval Date: 30.10.2018
82. Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP…4.00 % w/vAbsolute AlcoholIP…… 10.00%v/v Topical Solution(Additional Indication)
Composition: Composition:Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP…4.00 % w/vAbsolute AlcoholIP…… 10.00%v/v Topical Solution(Additional Indication)
Indication: For the treatment of acute lower back pain, osteoarthritis of the shoulder, elbow, wrist, spine, hip, knee and ankle.
Approval Date: 06.11.2018
83. Nepafenac Ophthalmic Suspension 0.3%w/v(Additional Indication)
Composition: Each ml contains: Nepafenac 3.0mg
Indication: For the treatment of post-operative pain and inflammation associated with cataract surgery.With the condition: to be sold by retail on the prescription of an ophthalmologist only.
Approval Date: 09.11.2018
84. Ibuprofen soft gelatine capsules 400mg. (New Dosage form)
Composition: Each soft gelatin capsule contains Ibuprofen 400mg
Indication: For chronic arthritic disorders and painful musculoskeletal conditions.
Approval Date: 20.11.2018
85. Fimasartan potassium trihydrate bulk drug and Fimasartan film-coated tablets 30mg/60mg/120mg
Composition: Fimasartan potassium trihydrate bulk drug and Fimasartan film-coated tablets 30mg/60mg/120mg
Indication: For the treatment of mild hypertension
Approval Date: 22.11.2018
86. Clobazam Oral suspension 2.5mg/ml(New Dosage form)
Composition: Each ml contains Clobazam 2.5mg
Indication:
1. Acute and chronic anxiety states.
2. As an adjunctive therapy in patients with refractory epilepsy, with the condition: To be sold by retail on the prescription of a Neurologist/ Psychiatrist only.
Approval Date: 30.11.2018
87. Everolimus tablets 2.5 mg(Additional Indication)
Composition: Each tablet contains: Everolimus 2.5 mg
Indication: Treatment of patients with Progressive neuroendocrine tumours of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease, Treatment of patients with Advanced Renal Cell Carcinoma (RCC).With the condition: To be sold by retail on the prescription of an oncologist only.
Approval Date: 05.12.2018
88. Clonazepam Mouth Dissolving tablets 0.25/0.5/1.0/2.0mg(New Dosage Form)
Composition: Each uncoated mouth dissolving tablet contains: Clonazepam 0.25/0.5/1.0/2.0 mg
Indication: Treatment of seizure disorders (Petit mal and its variants, akinetic and myoclonic seizures), Panic disorder & add-on therapy in acute mania.With the condition: To be sold by retail on the prescription of Neurologists or Psychiatrists only.
Approval Date: 10.12.2018
89. Divalproex Sodium Oral Solution 250mg/5ml(Additional Strength)
Composition: Each 5 ml contains: Divalproex 250mg
Indication: Monotherapy and adjunctive therapy in the treatment of patients with ‘complex partial seizures that occur either in isolation or in association with types of seizures for adult patients only.
Approval Date: 21.12.2018
90. Ivermectin Cream 1.0% w/w(New Dosage form)
Composition: Each Gram Contains: Ivermectin 1.0% w/w
Indication: Treatment of inflammatory lesions of rosacea.With the condition: To be sold by retail on the prescription of a dermatologist only.
Approval Date: 21.12.2018
91. Sacubitril/Valsartan (as sodium salt complex) and FDC of Sacubitril + Valsartan 50 (24+26)/100 (49+51)/200 (97+103) mg film-coated tablets
Composition: Sacubitril/Valsartan (as sodium salt complex) and FDC of Sacubitril + Valsartan 50 (24+26)/100 (49+51)/200 (97+103) mg film-coated tablets
Indication: To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction
Approval Date: 24.12.2018
92. Donepezil Hydrochloride Orally Disintegrating Strips(Additional dosage form)
Composition: Each Orally Disintegrating Strip Contains: Donepezil Hydrochloride 5/10 mg
Indication: For the treatment of mild to moderate severe Alzheimer’s Dementia.With the condition:-To be sold by retail on the prescription of Neurologists only.
Approval Date: 11.01.2019
93. Each Film-coated tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin + Vitamin D3 (Cholecalciferol) IP(10mg + 1000 IU) & (20mg + 1000 IU)
Composition: Each Film-coated tablet contains: Atorvastatin Calcium IP eq. to Atorvastatin + Vitamin D3 (Cholecalciferol) IP(10mg + 1000 IU) & (20mg + 1000 IU)
Indication: For the treatment of patients with hyperlipidemia.
Approval Date: 22.01.2019
94. Tapentadol Hydrochloride capsule 50mg(New dosage form)
Composition: Each capsule contains: Tapentadol Hydrochloride 50mg
Indication: For relief of moderate to severe acute pain in adults 18 years of age or older.
Approval Date: 30.01.2019
95. Fenspiride hydrochloride film-coated extended-release tablet 80 mg and Fenspiride hydrochloride bulk
Composition: Fenspiride hydrochloride film-coated 2 tablets 80 mg and Fenspiride hydrochloride bulk
Indication:
1. Acute Rhinosinusitis
2. Moderate persistent asthma as an add-on therapy
Approval Date: 04.02.2019
96. Bilastine tablets 20 mg and Bilastine Bulk
Composition: Bilastine tablets 20 mg and Bilastine Bulk
Indication: For symptomatic treatment of allergic rhino-conjunctivitis (seasonal and perennial) and urticaria in adults
Approval Date: 06.02.2019
97. Iguratimod film-coated tablets 25mg and Iguratimod Bulk
Composition: Iguratimod film-coated tablets 25mg and Iguratimod Bulk
Indication: For the treatment of active rheumatoid arthritis symptoms
Approval Date: 18.02.2019
98. Midodrine Hydrochloride tablet 2.5mg, 5mg and 10mg(Additional strength)
Composition: Each tablet contains: Midodrine Hydrochloride 2.5mg, 5mg and 10mg
Indication: It is indicated in the treatment of symptomatic orthostatic hypotension.With the condition:-To be sold by retail on the prescription of Cardiologists only.
Approval Date: 20.02.2019
99. Ribociclib film-coated tablet 200mg(Additional indication)
Composition: Ribociclib succinate 254.40mg eq. To Ribociclib 200mg
Indication: Ribocicib in combination with an aromatase inhibitor for the treatment of pre/peri-menopausal or post-menopausal women, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2(HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.With the condition: To be sold by retail on the prescription of an Oncologist only.
Approval Date: 13.03.2019
100. Each 1ml contains: Hydrocortisone Aceponate .......1.11mgGentamicin Sulphate IP.............1505 μg Miconazole Nitrate IP................15.1mgOily Suspension (For external use only)For Veterinary Use Only
Composition: Each 1ml contains: Hydrocortisone Aceponate .......1.11mgGentamicin Sulphate IP.............1505 μg Conazole Nitrate IP................15.1mgOily Suspension (For external use only)For Veterinary Use Only
Indication: For the treatment of acute otitis externa, and acute exacerbation of recurrent otitis externa associated with bacteria susceptible to Gentamicin and fungi susceptible to Miconazole, in particular Malassezia pachydermatis
Approval Date: 19.03.201
101. Each capsule contains: Glycopyrrolate USP equivalent to Glycopyrronium..............................12.5mcgFormoterol Fumarate Dihydrate … .12 mcg for inhalation
Composition: Each capsule contains: Glycopyrrolate USP equivalent to Glycopyrronium..............................12.5mcgFormoterol Fumarate Dihydrate … .12 mcg for inhalation
Indication: It is indicated for:-As a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)
Approval Date: 19.03.2019
102. Fingolimod Capsules 0.5mg and Fingolimod hydrochloride bulk
Composition: Fingolimod Capsules 0.5mg and Fingolimod hydrochloride bulk
Indication: For the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Approval Date: 25.03.2019
103. Azacitidine for injection 150mg/vial(Additional strength)
Composition: Each vial contains: Azacitidine. 150mg Lyophilized powder for injection(for subcutaneous or Intravenous use)
Indication: For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome.With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 25.03.2019
104. Lenvatinib capsule 4mg/10mg(Additional Indication)
Composition: Each capsule contains: Lenvatinib mesylate 4.90mg eq. To Lenvatinib 4mg, Lenvatinib mesylate 12.25 mg eq. To Lenvatinib 10mg.
Indication: For the first-line treatment of patients with unresectable hepatocellular carcinoma.With the condition: to be sold by retail on the prescription of an Oncologist only.
Approval Date: 26.03.2019
105. Primidone tablet 50mg(Additional Strength)
Composition: Each uncoated tablet contains: Primidone USP 50mg
Indication: It is indicated for the management of grand mal and psychomotor (temporal lobe) epilepsy. It is also of value in the management of focal or Jacksonian seizures, myoclonic jerks and akinetic attacks. Management of essential tremor.With the condition: To be sold by retail on the prescription of a neurologist only.
Approval Date: 15.04.2019
106. Paroxetine Hydrochloride IP Eq. to Paroxetine (as extended release) + Clonazepam (25mg+0.5mg & 12.5mg+0.5mg)(Additional Dosage form)
Composition: Each film-coated tablet contains: Paroxetine Hydrochloride IP Eq. to Paroxetine (as extended release) + Clonazepam (25mg+0.5mg & 12.5mg+0.5mg)(Additional Dosage form)
Indication: It is indicated for the treatment of patients with comorbid depression and anxiety.
Approval Date: 16.04.2019
107. Each Dispersible tablet contains: Abacavir Sulphate IP eq. to Abacavir ……………60mgLamivudine IP …………….30mg(Additional Dosage form)
Composition: Each Dispersible tablet contains: Abacavir Sulphate IP eq .to Abacavir …………… 60 mg, Lamivudine IP …………….30mg(Additional Dosage form)
Indication: In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV) infection in children
Approval Date: 23.04.2019
108. Each film-coated tablet contains: Dolutegravir Sodium Eq. to Dolutegravir…………………50mgEmtricitabine IP……………. 200mgTenofovir Alafenamide Fumarate eq. toTenofovir Alafenamide……….25mg
Composition: Each film-coated tablet contains: Dolutegravir Sodium Eq. to Dolutegravir…………………50mgEmtricitabine IP……………. 200mgTenofovir Alafenamide Fumarate eq. toTenofovir Alafenamide……….25mg
Indication: Indicated for the management of Human Immunodeficiency Virus (HIV) infections in adults weighing more than 40kg.
Approval Date: 23.04.2019
109. Remogliflozin etabonate bulk and Remogliflozin etabonate film-coated tablets 100 mg
Composition: Remogliflozin etabonate bulk and Remogliflozin etabonate film-coated tablets 100 mg
Indication: Indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycemic control as:-· Monotherapy when diet and exercise alone do not provide adequate glycemic control.· Add on therapy with metformin, together with diet and exercise, when these do not provide adequate glycemic control.
Approval Date: 26.04.2019
110. Amisulpride orodispersible tablet 50/100/200/300/400mg(New dosage form)
Composition: Each uncoated Oro dispersible tablet contains: Amisulpride 50/100/200/300/400mg
Indication: For acute and chronic schizophrenic disorders, in which positive and negative symptoms are prominent, including patients characterized by predominant negative symptoms.With the condition: To be sold by retail on the prescription of a Psychiatrist or
Approval Date: 11.05.2019
112. Concentration of Proteolytic enzyme enriched in the Bromelain topical gel
Composition: Concentrate of Proteolytic enzyme enriched in Bromelain topical gel
Indication: Indicated for the removal of eschar in adults with deep partial-and full-thickness thermal burns
Approval Date: 17.05.2019
113. Each uncoated tablet contains :Perindopril Erbumine BP ……4mgIndapamide IP .......1.25mgAmlodipine Besilate IP …...5mg
Composition: Each uncoated tablet contains :Perindopril Erbumine BP ……4mgIndapamide IP .......1.25mgAmlodipine Besilate IP …...5mg
Indication: For treatment of moderate to severe hypertension
Approval Date: 20.05.2019
114. Eye Drops containsAlcaftadine ….. 0.25%w/vKetorolac Tromethamine ….0.4%w/v
Composition: Eye Drops containsAlcaftadine ….. 0.25%w/vKetorolac Tromethamine ….0.4%w/v
Indication: For the treatment of ocular itching and other symptomatic associated allergic conjunctivitis.
Approval Date: 21.05.2019
115. Azilsartan medoxomil tablet 20/40/80mg(Additional lower Strength)
Composition: Each uncoated tablet contains: Azilsartan Kamedoxomil equivalent to Azilsartan medoxomil 20/40/80mg
Indication: Indicated for the treatment of hypertension in adult patients, either alone or in combination with other antihypertensive agents.With the condition: To be sold by retail on the prescription of a Cardiologist only.
Approval Date: 27.05.2019
116. Everolimus Tablet 0.25mg/0.5mg/0.75mg/1.0mg(Additional indication)
Composition: Each film-coated tablet contains: Everolimus 0.25mg/0.5mg/0.75mg/1.0mg
Indication: Prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving an allogeneic renal or cardiac transplant. In kidney and heart transplantation, Certican should be used in combination with ciclosporin for microemulsion and Corticosteroids. With the condition: To be sold by retail on the prescription of a cardiologist only.
Approval Date: 27.05.2019
117. Each tablet containsSulfamethaxazole IP ….800mgTrimethoprim IP ….160mgIsoniazid IP ….300mgPyridoxine Hydrochloride IP…..25mg
Composition: Each tablet containsSulfamethaxazole IP ….800mgTrimethoprim IP ….160mgIsoniazid IP ….300mgPyridoxine Hydrochloride IP…..25mg
Indication: For the prevention of tuberculosis, bacterial pneumonia, malaria and isosporiasis, and to reduce mortality and hospitalizations in HIV infected patients with advanced disease and without active TB.
Approval Date: 28.05.2019
118. Diclofenac sodium 2% Topical Solution(New route of administration)
Composition: Each 1 gram of solution contains: Diclofenac sodium 20mg
Indication: For the treatment of pain of osteoarthritis of the knees.
Approval Date: 03.06.2019
119. Each Film Coated Tablet Contains :1. Metoprolol Succinate IP …..47.5mgEq. to Metoprolol Tartarate ….50mg(As Extended Release)Cilnidipine …...10mgTelmisartan IP ……40mg2. Metoprolol Succinate IP …..23.75mgEq. to Metoprolol Tartarate ….25mg(As Extended Release)Cilnidipine …...10mgTelmisartan IP ……40mg
Composition: Each Film Coated Tablet Contains :1. Metoprolol Succinate IP …..47.5mgEq. to Metoprolol Tartarate ….50mg(As Extended Release)Cilnidipine …...10mgTelmisartan IP ……40mg2. Metoprolol Succinate IP …..23.75mgEq. to Metoprolol Tartarate ….25mg(As Extended Release)Cilnidipine …...10mgTelmisartan IP ……40mg
Indication: It is indicated for the treatment of patients with uncontrolled essential hypertension and stable ischemic heart disease
Approval Date: 04.06.2019
120. Menotrophin injection 600 IU/ml, 1 ml & 2 ml multi-dose vial (Highly purified)
Composition: Menotrophin injection 600 IU/ml, 1 ml & 2 ml multi-dose vial (Highly purified)
Indication: Menotropin is indicated for the treatment of female and male infertility in the following conditions: Anovulation, including Polycystic Ovarian Disease (PCOD), in women who have been unresponsive to the treatment with Clomiphene citrate. Women undergo controlled ovarian hyperstimulation to induce the development of multiple follicles for Assisted Reproductive Technologies (ART).Hypogonadotropic hypogonadism in men
Approval Date: 04.06.2019
121. Artesunate for injection 120mg with phosphate buffer 0.3M(Additional strength)
Composition: Each combi pack contains: a) Artesunate for injection 120 mg. Each vial contains: Artesunate IP 120 mg, Phosphate Buffer 0.3M (12ml). Each ampoule contains: Anhydrous Disodium Hydrogen Phosphate BP 4.0% w/vPotassium dihydrogen phosphate BP 0.2% w/v
Indication: Indicated for the treatment of severe falciparum malaria in areas where there is evidence of quinine resistance
Approval Date: 26.06.2019
122. Injection For (Veterinary Use)Each ml Contains Buparvaquone…..50mgFurosemide IP .…55mgSorbitan mono oleate BP …..100mg(As preservative)Oil base ……q.s.
Composition: Injection For (Veterinary Use)Each ml Contains Buparvaquone…..50mgFurosemide IP .…55mgSorbitan mono oleate BP …..100mg(As preservative)Oil base ……q.s.
Indication: For the treatment of theileriosis (East Coast Fever), particularly for advanced cases with pulmonary edema.
Approval Date: 27.06.2019
123. Dry Powder For Inhalation. Each Capsule Contains: Glycopyrronium (As Glycopyrrolate USP) …..25mcgFormoterol Fumarate Dihydrate.… 12 mcg
Composition: Dry Powder For Inhalation. Each Capsule Contains: Glycopyrronium (As Glycopyrrolate USP) …..25mcgFormoterol Fumarate Dihydrate.… 12 mcg
Indication: Indicated as a maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease(COPD)
Approval Date: 28.06.2019
124. Rifapentine 150mg film-coated tablet
Composition: Rifapentine 150mg film-coated tablet
Indication: “For the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in adults and children 2 years and older who are at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph). Active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection. Rifapentine Tablets 150mg must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection.”
Approval Date: 08.07.2019
125. Each Film Coated Tablet contains: Azilsartan Kamedoxomil eq. To Azilsartan Medoxomil.........................40mgChlorthalidone IP …............6.25mg(In additional strength)
Composition: Each Film Coated Tablet contains: Azilsartan Kamedoxomil eq. To Azilsartan Medoxomil.........................40mgChlorthalidone IP …............6.25mg(In additional strength)
Indication: For the treatment of mild to moderate hypertension.
Approval Date: 09.07.2019
126. Each Film Coated Tablet contains: Tadalafil IP + Dapoxetine Hydrochloride IP Eq. To Dapoxetine (20mg + 60mg, 20mg + 30mg & 10mg + 30mg)
Composition: Each Film Coated Tablet contains: Tadalafil IP + Dapoxetine Hydrochloride IP Eq. To Dapoxetine (20mg + 60mg, 20mg + 30mg & 10mg + 30mg)
Indication: For the treatment of co-existing Erectile Dysfunction and Premature Ejaculation in men 18 to 64 years of age.
Approval Date: 23.07.2019
127. Tranexamic acid injection IP 100mg/ml(Additional Indication)
Composition: Each ml contains: Tranexamic acid IP 100 mg/ml
Indication: Indicated for short-term use in prophylaxis and treatment in patients at high risk of per-and post-operative hemorrhage following: a) Prostatectomy.b) Conization of the cervix.c) Surgical procedures and dental extractions in hemophiliacs
Approval Date: 26.07.2019
128. Rivaroxaban tablets 2.5mg(Add. Indication)
Composition: Rivaroxaban tablets 2.5mg
Indication: Rivaroxaban 2.5mg tablet, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.With the condition:-To be sold by retail on the prescription of Cardiologists only.
Approval Date: 30.07.2019
129. Olaparib 100 mg and 150 mg tablet(Additional Indication)
Composition: Olaparib 100 mg and 150 mg tablets
Indication: for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. With the condition:-To be sold by retail on the prescription of an Oncologist only.
Approval Date: 30.07.2019
130. Tapentadol Hydrochloride 25,000 milligram (mg) Capsules(Additional Lower Strength)
Composition: Tapentadol Hydrochloride 25.000 milligram (mg) Capsules
Indication: For relief of moderate to severe acute pain in adults 18 years of age or older
Approval Date: 31.07.2019
132. Leuprolide 22.50mg depot Injection Powder for prolonged-release suspension for injection (Depot injection for I.M. use only)(Add. strength)
Composition: Each vial contains: Leuprolide acetate 22.5mg
Indication: Treatment of advanced Prostatic cancer.With the condition:-To be sold by retail on the prescription of an Oncologist only.
Approval Date: 07.08.2019
133. Clobazam Tablets IP 2.5mg & 7.5mg(Add. lower strength).
Composition: Each tablet contains: Clobazam 2.5mg & 7.5mg
Indication: As an adjunctive therapy in patients with refractory epilepsy.With the condition:-To be sold by retail on the prescription of a Neurologist/ Psychiatrist only.
Approval Date: 07.08.2019
134. Sildenafil for oral suspension 10mg/ml(Add. Indication)
Composition: Each ml of reconstituted suspension contains: Sildenafil citrate IP equivalent to Sildenafil 10mg
Indication: For the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. With the condition:-To be sold by retail on the prescription of a cardiologist only.
Approval Date: 09.08-2019
135. FDC of Bictegravir, Emtricitabine and Tenofovir alafenamide 50mg/200mg/25mg tablets
Composition: FDC of Bictegravir, Emtricitabine and Tenofovir alafenamide 50mg/200mg/25mg tablets
Indication: For the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per ml) on a stable antiretroviral regimen for at least 3 month with no history of treatment failure and no known substitutions associated with resistance to Bictegravir, Emtricitabine and Tenofovir alafenamide
Approval Date: 09.08-2019
136. Levomilnacipran ER capsules 20mg/40mg/80mg/120mg
Composition: Levomilnacipran ER capsules 20mg/40mg/80mg/120mg
Indication: For the treatment of major depressive disorder
Approval Date: 13.08.2019
137. Each Film Coated Tablet contains:Remogliflozin Etabonate + Metformin Hydrochloride IP (100mg + 500mg & 100mg + 1000mg)
Composition: Each Film Coated Tablet contains:Remogliflozin Etabonate + Metformin Hydrochloride IP (100mg + 500mg & 100mg + 1000mg)
Indication: Indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control:1. In patients insufficiently controlled on their maximally tolerated dose of metformin alone 2. In patients already being treated with the combination of remogliflozin and metformin as separate tablets.
Approval Date: 14.08.2019
138. Each Film Coated Tablet contains: Cephalexin IP (Extended Release) + Potassium Clavulanate Diluted IP eq. to Clavulanic acid (375mg + 125mg & 750mg + 125mg)
Composition: Each Film Coated Tablet contains: Cephalexin IP (Extended Release) + Potassium Clavulanate Diluted IP eq. to Clavulanic acid (375mg + 125mg & 750mg + 125mg)
Indication: For the treatment of upper respiratory tract infections (URTI) and uncomplicated skin and soft tissue infections.
Approval Date: 14.08.2019
139. Pantoprazole dual-release gastro- resistant tablet 80mg(New Dosage form)
Composition: Each dual-release gastro- resistant tablet contains: Pantoprazole sodium equivalent to Pantoprazole 80mg
Indication: For the treatment of moderate to severe refractory Gastro-oesophageal reflux disease (GERD) for 4 weeks only.
Approval Date: 02.09.2019
140. Pirfenidone tablet 400 mg(Add. Strength)
Composition: Each film-coated tablet contains: Pirfenidone 400mg
Indication: For the treatment of idiopathic pulmonary fibrosis.With the condition:-To be sold by retail on the prescription of a Pulmonologist only.
Approval Date: 02.09.2019
141. Olopatadine HCI ophthalmic solution 0.7% w/v(Add. strength)
Composition: Each ml contains: Olopatadine HCI 0.7% w/vBenzalkonium chloride 0.015%w/v
Indication: For the treatment of ocular itching associated with allergic conjunctivitis.With the condition:-To be sold by retail on the prescription of an ophthalmologist only.
Approval Date: 06.09.2019
142. Algard HWS-256 (didecyl dimethyl ammonium chloride 10.14% w/w + n-Alkyl dimethyl benzyl ammonium chloride 6.76% w/w
Composition: Algard HWS-256 (didecyl dimethyl ammonium chloride 10.14% w/w + n-Alkyl dimethyl benzyl ammonium chloride 6.76% w/w
Indication: Surface disinfectant for persistent disinfection of all inanimate surfaces
Approval Date: 09.09.2019
143. Safinamide methane sulphonate bulk drug and Safinamide tablets 50, 100mg
Composition: Safinamide methane sulphonate bulk drug and Safinamide tablets 50, 100mg
Indication: For the treatment of adult patients with idiopathic Parkinson's disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other Parkinson's disease (PD) medicinal products in mid to late stage fluctuating patients.
Approval Date: 09.09.2019
144. Bosutinib bulk and Bosutinib tablets 100mg,
Composition: Bosutinib bulk and Bosutinib tablets 100mg,
Indication: For the treatment of adult patients with:1) Newly diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+CML)2) Chronic phase, accelerated phase (AP), or blast phase (BP) Ph+CML with resistance or intolerance to prior therapy.
Approval Date: 09.09.2019
145. Algard - R-82 (octyldecyl dimethyl ammonium chloride 6.510 w/w + Dioctyl dimethyl ammonium chloride 2.604% w/w + Didecyl dimethyl ammonium chloride 3.906% w/w + Alkyl dimethyl benzyl ammonium chloride 8.680% w/w
Composition: Algard - R-82 (octyldecyl dimethyl ammonium chloride 6.510 w/w + Dioctyl dimethyl ammonium chloride 2.604% w/w + Didecyl dimethyl ammonium chloride 3.906% w/w + Alkyl dimethyl benzyl ammonium chloride 8.680% w/w
Indication: Surface disinfectant for persistent disinfection of all inanimate surfaces (Against pathogens as annexed)
Approval Date: 09.09.2019
146. Ibrutinib hard gelatin capsule 140mg(Add. indication)
Composition: Each capsule contains: Ibrutinib 140mg
Indication: For the treatment of patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).With the condition:-To be sold by retail on the prescription of an Oncologist only.
Approval Date: 11.09.2019
147. Ibrutinib hard gelatin capsule 140mg(Add. indication)
Composition: Each capsule contains: Ibrutinib 140mg
Indication: For the treatment of patients with Waldenstrom's macroglobulinemia
Approval Date: 11.09.2019
148. Each Film Coated Tablet contains: Saxagliptin Hydrochloride 5.95mg Eq. To Saxagliptin........................5mgDapagliflozin Propanediol monohydrate 12.3mg Eq. To Dapagliflozin.........10mg
Composition: Each Film Coated Tablet contains: Saxagliptin Hydrochloride 5.95mg Eq. To Saxagliptin........................5mgDapagliflozin Propanediol monohydrate 12.3mg Eq. To Dapagliflozin.........10mg
Indication: Indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus (T2DM).Not indicated for use in patients with type 1 diabetes. Not to be used for the treatment of diabetic ketoacidosis.
Approval Date: 24.09.2019
149. Droxidopa bulk drug and Droxidopa capsules 200mg/300mg
Composition: Droxidopa bulk drug and Droxidopa capsules 200mg/300mg
Indication: For the treatment of orthostatic dizziness, lightheadedness or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure (Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure), dopamine beta-hydroxylase deficiency and non-diabetic autonomic neuropathy.
Approval Date: 24.09.2019
150. Desonide Ointment 0.05%(Add. Dosage form)
Composition: Desonide topical ointment 0.05%
Indication: for sub-acute to chronic steroid-responsive dermatoses.
Approval Date: 26.09.2019