Complete list of CDSCO approved drugs in India

Fedley Healthcare

3 Sept 2025 · 47 min read

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 are year wise and department wise. Also, there are numerous lists which a manufacturer has to go through to find the status of the drug which 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 has 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 at one place in an easy searchable format. We are committed to update this list as and when the list of new approved drugs are issued by CDSCO. This initiative has been taken after successful and widely applauded list of ban drugs and list of solubility of Active Pharmaceutical Ingredients has been published on our website.

About fedleyhealthcare : fedleyhealthcare 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 having 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, who not only help you with the filing process but 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 have helped us won accolades among our clients.

Sr. No.

Name of the Product

Composition

Indication

Date of Approval

Pegaspargase

Each vial contains:Pegaspargase 3750 IU per vial

As a component of multi agent chemotherapeutic regiment for the treatment of patients with acute lymphoblastic leukaemia who are hypersensitive to L-Asparaginase.

04.01.2018

Cefditoren Pivoxil dry powder for suspension 100mg/5ml(Additional Indication)

Each 5ml reconstituted suspension contains:Cefditoren Pivoxil equivalent to Cefditoren 100mg

For the treatment of mild to moderate infection also in children’s of (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

30.03.2017

Tenofovir Alafenamide Hemifumarate Bulk Emtricitabine 200mg/200mg +Tenofovir Alafenamide 10/25 mg Tablets

In combination with other antiretroviral agents for treatment of Human Immunodeficiency Virus type-1 (HIV-1) infection in adults and adolescents with aged 12 years and older

10.01.2018

Emtricitabine 200mg/200mg +Tenofovir Alafenamide 10/25 mg Tablets

In combination with other antiretroviral agents for treatment of Human Immunodeficiency Virus type1 (HIV-1) infections in adults and adolescents with aged 12 years and older.

10.01.2018

Clofarabine Bulk & Injection 20 mg/20ml vial

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 upon response rate

16.01.2018

Denaverine Hydrochloride Injection (Vet.)

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 corrrection of uterine torsions; improvement of the conditions for foetotomy; regulation of labour contractions of the utreus Dogs: Activation of Interrupted parturition

16.01.2018

Eltrombopag olamine tablets 12.5mg(Additional strength & indication)

Each film coated tablet contains:Eltrombopag olamine equivalent to Eltrombopag olamine as free acid 12.5mg

1. Chronic ITP : for AdultsFor 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 increase 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 Haematologist only

06.02.2018

Fipronil 6.1 % m/v + Permethrin 54.5% m/V spot on solution for Dog (Vet.)

In dogs, to be used against infestations with fleas and/or ticks when repellant (anti feeding) activity is necessary against sand-flies and/or mosquitoes

20.02.2018

Paziquantel 0.0065 g + Abamectin 0.00025 g tablets for cat (Vet)

In infestation of cats with endoparasites tapewoms (teniae), flukes, roundworms (nematodes); with ectoparasites - lice, fleas, pasture ticks, notedric mange (feline scabies), "walking" dandruff (cheyletiellosis) and other mange, and particularly in cases of complex endo and ectoparasitic invasion.

20.02.2018

Cadexomer Iodine Bulk & Powder 100 % w/w (contain 0.9 % w/v Iodine)orcadexomer Iodine Ointment 500 mg (contains 0.9% w/v iodine)

For the treatment of chronic exuding wounds such as leg ulcers, pressure ulcers and diabetes ulcers infected traumatic and surgical wounds

05.03.2018

Alectinib Capsules 150mg(Additional Indication)

Each hard gelatin capsule contains: Alectinib 150mg equivalent to Alectinib hydrochloride 161.3mg

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 Oncologist only.

05.03.2018

Each film coated tablet contains:Dolutegravir sodium equivalent toDolutegravir ……………… 50mgLamivudine IP……………. 300mgTenofovir Disoproxil Fumarate IP ……. 300mgeq. to Tenofovir Disoproxil …… 245mg

For the management of Human Immunodeficiency Virus (HIV) infections in adults weighing more than 40kg.

08.03.2018

Methotrexate injection prefilled syringe 15mg/0.3ml, 20mg/0.4ml and 25mg/0.5ml(Additional strength & indication)

Each 0.3ml prefilled syringe contains: Methotrexate 15mgEach 0.4ml prefilled syringe contains: Methotrexate 20mgEach 0.5ml prefilled syringe contains: Methotrexate 25mg

It is indicated in treatment of1. 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 patie

09.03.2018

Each film coated tablet contains:Abacavir Sulphate USP eq .to Abacavir………………..600mgDolutagravir Sodium eq. to Dolutagravir……………50mg Lamivudine USP……….300mg

Each film coated tablet contains:Abacavir Sulphate USP eq .to Abacavir………………..600mgDolutagravir Sodium eq. to Dolutagravir……………50mgLamivudine USP……….300mg

For the treatment of Human Immunodeficiency Virus (HIV) infection in adults weighing more than 40kg.

12.03.2018

Dalfampridine Bulk & Film coated extented release tablet 10 mg

For treatment to improve walking in patients with multiple Sclerosis (MS)

12.03.2018

Ulipristal Acetate 5 mg tablets

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

14.03.2018

Sildenafil power for oral suspension 10mg/ml(Additional dosage form)

Each ml of reconstituted suspension contains:Sildenafil citrate equivalent to 10mg, Sodium benzoate 4.375mg

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.Paediatric population: Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics 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 Cardiologist only.

20.03.2018

Fulvestrant 250mg/5ml injection(Additional Indication)

Each 5ml pre-filled syringe contains:Fulvestrant 250mg ethanol (96%)-10% w/v

For the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapyWith the condition: to be sold by retail on the prescription of Oncologist only.

20.03.2018

Each ml cutaneous solution contains:Chlorhexidine gluconate solution IP Eq. to Chlorhexidine gluconate ……. 20 mgIsopropyl Alcohol IP …………… 0.70 ml

For disinfectant of the skin prior to invasive medical procedures and maintenance of device insertion sites.

22.03.2018

Bendamustine hydrochloride injection 90mg/ml(0.5ml vial & 2.0 ml vial)(Additional Indication)

Each ml contains:Bendamustine hydrochloride 90mg ethanol 4.33% w/v

Front line 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 time of diagnosis precluding the use of thalidomide or bortezomib containing treatment.With the condition: to be sold by retail on the prescription of Oncologist/Specialist only.

23.03.2018

Each film coated tablet contains:Canagliflozin + Metformin HCL(50mg+500mg, 50mg+850mg, 50mg+1000mg, 150mg+500mg, 150mg+850mg, 150mg+ 1000mg) .

Each film coated tablet contains:Canagliflozin + Metformin HCL(50mg+500mg, 50mg+850mg, 50mg+1000mg, 150mg+500mg, 150mg+850mg, 150mg+ 1000mg)

Indicated as an adjunct to diet and exercise to improve glycaemic control in adult 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.

27.03.2018

Ulipristal Acetate bulk

02.04.2018

Dydrogesterone tablet 10mg(Additional Indication)

Each film coated tablet contains:Dydrogesterone 10mg

Luteal support as part of an Assisted Reproductive Technology (ART) treatment.With the condition: to be sold by retail on the prescription of Gynaecologist only

06.04.2018

Febuxostat tablet 60mg & 20mg(Additional Strength)

Each film coated tablet contains:Febuxostat 60mg & 20mg

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)

06.04.2018

Posaconazole injection 300mg/16.7ml (18mg/ml)(Additional Strength & Dosage Form)

Each injection contains:Posaconazole 300mg/16.7ml

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 Specialist only.

13.04.2018

Riociguat bulk & 0.5mg/1.0mg/1.5mg/2.0mg/2.5 mg tablet

For the treatment of persistent/ recurrent chronic Thromoembolic pulmonary Hypertension (CTEPH) WHO Group 4) After surgical treatment or imoperable CTEPH to improve exercise capacity and WHO function

16.04.2018

Each ml contains:i) Bupivacaine Hydrochloride IP 1.25mg Eq to anhydrous Bupivacaine Hydrochloride 1.185mgFentanyl Citrate IP Eq to Fentanyl 2.0mcg Injectionii) Bupivacaine Hydrochloride IP 1.0mg Eq to anhydrous Bupivacaine Hydrochloride 0.948mgFentanyl Citrate IP Eq to Fentanyl 2.0 mcg Injection

For maintaining the analgesia postoperatively. For maintaining analgesia during labour

17.04.2018

Baricitinib 2mg/4mg film coated Tablets

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 modification anti-rheumatic drugs. Baricitinib may be used as monotherapy or in combination with methotrexate

07.05.2018

Teriflunomide tablet 7mg(Add. Lower strength)

Each film coated tablet contains:Teriflunomide 7mg

For the treatment of patients with relapsing form of multiple sclerosis. With the condition: to be sold by retail on the prescription of Neurologist only.

07.05.2018

Apremilast film coated tablet 10/20/30mg(Additional Indication)

Each film coated tablet contains:Apremilast-10mg, 20mg,30mg

For the treatment of adult patients with Active psoriatic Arthritis.

07.05.2018

Aripiprazole tablet 2mg(additional strength)

Each uncoated tablet contains:Aripiprazole-2mg

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 Psychiatrist only.

11.05.2018

Dextromethorphan HBr Lozenges 10mg(Add. dosage form & strength)

Each lozenges contains:Dextromethorphan HBr-33.33% Complex 30mg eq. to Dextromethorphan HBr 10mg

Cough suppressant for the relief of acute non-productive (dry, tickly) cough associated with respiratory tract infection in adult patients only.

11.05.2018

Voglibose Orally Disintegrating Strips 0.2mg(Modified dosage form)

Each Orally Disintegrating Strips contains:Voglibose 0.2mg & 0.3mg

For improvement of parandial hyperglycaemia 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.

11.05.2018

Vortioxetine Hydrochloride 5 mg/10mg/15mg/20mg

for the treatment of major depressive disorder in adults

14.05.2018

Tranexamic acid tablet 1000mg(Additional strength)

Each film coated tablet contains:Tranexamic acid-1000mg.

For the treatment of menorrhagia

21.05.2018

Eltrombopag Olamine Tablet 75mg(Additional strength)

Each film coated tablet contains:Eltrombopag Olamine as free acid-75mg

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 increase 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:a. Enable the intiation of interferon based therapy.b. Optimize interferon based therapy 3. For the treatment of patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy4. For the treatment of thrombocytopenia in paediatric 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 increase 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 Hematologist only.

29.05.2018

Thyroxine Sodium Tablet 37.5 mcg(Additional strength)

Each uncoated tablet contains:Thyroxine Sodium eq. to Anhydrous Thyroxine Sodium. 37.5 mcg.

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 euthyroidgoites, including thyroid nodules, sub-acute or chronic lymphocytic thyroiditis (Hashimoto's) multi-nodular goiter and in conjuction with surgery and radioactive iodine therapy in the management of thyrotropin-dependent well differentiated papillary or follicular carcinoma of the thyroid.

08.06.2018

Dabrafenib Hard Gelatin Capsule 50mg,& 75mg(Additional indication)

Each Hard Gelatin Capsule contains:Dabrafenib Mesylate eq. to Dabrafenib 50mg & 75mg

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 Oncologist only.

08.06.2018

Trametinib Tablet 0.5mg & 2mg(Additional indication)

Each Film coated tablet contains:Trametinib 0.5mg & 2mg

Trametinib in combination with Dabrafenib for the treatment of adult patients with advance non-small cell lung cancer with a BRAF V 600 mutation. With the condition: to be sold by retail on the prescription of Oncologist only.

08.06.2018

Vardenafil Hydrochloride Trihydrate Bulk and 2.5mg/5mg/10 mg/20 mg tablets

Treatment of erectile dysfunction in adult men

11.06.2018

Trientine Hydrochloride Bulk and 250 mg capsule

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 effect.

11.06.2018

Each film coated tablet contains :Daclatasvir Dihydrochloride Eq to Daclatasvir………..60 mgSofosbuvir……………....400 mg

For the treatment of patient with chronic Hepatitis C virus (HCV) genotype 3 infection

12.06.2018

Azacitidine for injection 50mg/vial(Additional strength)

Each vial contains:Azacitidine….... 50mg Lyophilized powder for injection(for Subcutaneous or Intravenous use)

For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome.With the condition: to be sold by retail on the prescription of Oncologist only.

22.06.2018

Nilotinib Capsules 50mg(Additional strength & add. indication)

Each Capsule contains:Nilotinib 50mg

1. Paediatric patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukaemia (CML) in the chronic phase.2. 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 Oncologist only.

22.06.2018

Gadoteridol injection

To visualise 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.

25.06.2018

Fipronil 50mg/134 mg/268mg/402mg spot on solution for cats and dogs

For treatment of flea and tick infestation in cats and dogs (for veterinary use only)

25.06.2018

FDC of Emtricitabine 200 mg and Tenofovir Alafenamide 25 mg tablets

In combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight atleast 35 kg) infected with Human Immunodeficiency Virus type-1 (HIV-1)

25.06.2018

Each vial contains:Meropenam IP eq. to Anhydrous Meropenam……..1gmSodium Carbonate IP Eq. toSodium ……90.2 mgSulbactum Sodium USP Eq. to Sulbactum………1gm Injection

For the treatment of lower respiratory tract infection caused by gram negative bacteria in adults only.

25.06.2018

Imidacloprid and Flumethrini) 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

For the treatment and prevention against fleas, Ticks & Lice and For reducing the risk of Vector-Borne Disease transmission.

26.06.2018

Each Film coated tablet contains:Azilsartan Kamedoxomil eq to Azilsartan Medoxomil + Chlorthalidone IP(40mg+25mg,40mg + 12.5mg)

Each Film coated tablet contains:Azilsartan Kamedoxomil eq to Azilsartan Medoxomil + Chlorthalidone IP (40mg+25mg,40mg + 12.5mg)

For the treatment of mild to moderate hypertension

09.07.20

FDC of Azilsartan + chlorthalidone (40 mg + 12.5 mg)andAzilsartan + chlorthalidone (40 mg + 25 mg) tablet

For the treatment of mild to moderate hypertension in adults

09.07.2018

Fulvestrant 250mg/5ml injection(Additional indication)(for IM use only)

Each 5ml pre-filled syringe contains:Fulvestrant USP 250mg Ethanol (96%) BP-10% w/v

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 Oncologist only.

13.07.2018

Ganciclovir Sodium powder for Infusion 500mg(Additional indication)(for IV use only)

Each vial contains:Ganciclovir 500mg(In the form of the sodium salt)

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.

13.07.2018

Nepafenac Ophthalmic Suspension 0.3%w/v(Additional strength)

Each ml contains:Nepafenac 3.0mg

For the treatment of pain and inflammation associated with cataract surgery. With the condition: to be sold by retail on the prescription of Ophthalmologist only.

13.07.2018

Tadalafil Orally Disintegrating Strip 5mg(Additional strength)

Each Orally Disintegrating Strip contains:Tadalafil 5mg

For the treatment of Erectile Dysfunction

13.07.2018

Each capsules contains:Glycopyrronium (As Glycopyrrolate USP)…… 25mcgFormoterol Fumarate Dihydrate IP Eq. to Formoterol Fumarate……….6mcg(Capsule for inhalation)

Each capsules contains:Glycopyrronium (As Glycopyrrolate USP)…… 25mcgFormoterol Fumarate Dihydrate IP Eq. to Formoterol Fumarate……….6mcg

For the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema

16.07.2018

For the treatment of Erectile Dysfunction(Additional indication)

Each film coated tablet contains :Delamanid …..... 50mg

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 Revised National Tuberculosis Control Program (RNTCP).

27.07.2018

Osimertinib Film coated tablet 40mg and 80mg(Additional indication)

Each film coated tablet contains:Osimertinib 40mg, 80mg

As first-line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumors 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 Oncologist only.

03.08.2018

FDC of Ceftolozane (1.0 gm) and Tazobactum (0.5 gm) injection

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 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 ICU setting only.

06.08.2018

Olaparib film coated tablets (100mg, 150 mg)

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.

13.08.2018

Nicotine Polacrilex Orally disintegrating strips 2mg & 4mg(New dosage form)

Each Orally disintegrating strips contains:Nicotine Polacrilex eq. to Nicotine 2mg, 4mg

To reduce the withdrawal symptoms, including nicotine craving, associated with quitting the smoking and quitting chewed tobacco and gutkha containing tobacco

17.08.2018

Each combikit contains:Part A: One film coated tablet of Atazanavir Sulphate and Ritonavir tablet.Each film coated tablet contains: Atazanavir Sulphate IP eq.toAtazanavir ..................................... 300mgRitonavir IP… ............................... 100mgPart B: One film coated tablet of Abacavir Sulphate and Lamivudine tabletEach film coated tablet contains: Abacavir Sulphate IP eq toAbacavir ............................................ 600mgLamivudine IP… ............................... 300mg

For management of Human Immunodeficiency Virus (HIV) infections

17.08.2018

Each sachet contains:( Granules in sachet)Lopinavir IP………..40mgRitonavir IP………..10mg(Additional Dosage Form)

Combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (14 days and older)

21.08.2018

Ethyl esters of Iodidzed fatty acids of Poppy Seed Oil solution for injection(Lipodol Ultra Fluid 10ml)(Additional Indication)

Each ampoule (10ml) contains: Ethyl esters of Iodidzed fatty acids of Poppy Seed Oil Iodine content 48% i.e. 480mg iodine per ml

Conventional Trans-Arterial Chemo-Embolization (cTACE) of Hepatocellular Carcinoma (HCC) in adults.

06.09.2018

Methylcobalamin nasal spray 250mcg/spray(New Dosage form)

Each 0.1ml contains:Methylcobalamin 500mcgBenzalkonium chloride (As preservative) 0.02% w/v

Treatment of Vitamin B12 deficiency in patients without having neurological involvement.

28.09.2018

Apomorphine Hydrochloride injection 10mg/ml (2ml and 5ml Ampoule)(subcutaneous use only)(Add. Dosage form and add. indication)

Each ml contains:Apomorphine hydrochloride 10mg

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 decarboxylasee inhibitor) and/or other dopamine agonists.With the condition: to be sold by retail on the prescription of Neurologist only

28.09.2018

Carfilzomib for Injection 30mg/vial (Lyophilized injection)(Additional Strength)

Each vial contains:Carfilzomib 30mg

· 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 Oncologist only.

28.09.2018

Ceftazidime 2gm/Avibactam 0.5 gm powder for concentrate for solution for infusion

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

01.10.2018

Each film coated tablet contains:Dapagliflozin…………5mgMetformin HCL ……. 1000mg(Immediate Release)

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.

03.10.2018

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 hydrochloride8.085mg eq. to Ivabradine 7.5mg.

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 doses level for:i. The symptomatic treatment of chronic stable angina pectoris in coronary artery disease patientsii. The treatment of chronic heart failure (II-IV NYHA-Class) withsystolic dysfunction.

03.10.2018

Sodium Alginate IP 250mg + Sodium Bicarbonate IP 133.5mg + Calcium Carbonate IP 80mg per 5ml oral liquid.

Indicated for the treatment of heartburn and indigestion.

04.10.2018

Each film coated tablet contains:Memantine Hydrochloride USP…. 10mgDonepezil Hydrochloride IP…….. 10mg(Additional Strength)

For the treatment of moderate to severe Alzheimer’s disease.

16.10.2018

Each film coated tablet contains:Piperaquine Tetraphosphate as Piperaquine Tetraphosphate Tetrahydrate (QP)….160mgDihydroartemisinin (DHA) .... 20mg(Additional Strength)

Each film coated tablet contains:Piperaquine Tetraphosphate as Piperaquine Tetraphosphate Tetrahydrate (QP)...160mgDihydroartemisinin (DHA) .... 20mg

For the treatment of uncomplicated Plasmodium Falciparum Malaria in paediatric and adolescent patients.

16.10.2018

Each uncoated tablet contains:Calcium Citrate US ...............1200mgeq. to elemental Calcium.........252mgCalcitriol IP.............................0.25mcg(Additional indication)

It is indicated for:-1. Treatment of Hypocalcaemia / 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 corticosteroidinduced osteoporosis in patients with renal impairment commencing oral steroid therapy in a dose and regimen expected to result in a significant bone loss.5. Established osteoporosis / Post Menopausal Osteoporosisdiagnosed by objective measuring techniques, such as densitometry, or by radiographic evidence of a traumatic fracture in patients with renal impairment.

16.10.2018

Nilotinib hard Capsules 150mg & 200mg (Additional indication)

Each Capsule contains: Nilotinib 150mg & 200mg

1. Treatment of Paediatric patients with newly diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukaemia (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 Oncologist only.

18.10.2018

Dasatinib film coated tablet 20mg, 50mg, 70mg and 100mg (Additional indication)

Each film coated tablet contains: Dasatinib 20mg, 50mg, 70mg and 100mg

Treatment of Paediatric patients with Philadelphia Chromosome Positive Chronic myeloid leukemia (Ph+ CML) in chronic phaseWith the condition: to be sold by retail on the prescription of Oncologist only.

18.10.2018

Nifedipine Extended Release Tablet 60mg (Add. strength and indication)

Each Extended release film coated tablet contains: Nifedipine 60mg

Vasospastic Angina,· Chronic stable Angina (Classical effort-Associated Angina),· Hypertension.With the condition: to be sold by retail on the prescription of Cardiologist only.

18.10.2018

Evogliptin Tartrate Bulk and Tablets 5 mg

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

22.10.2018

Lorcaserin Hydrochloride Bulk and 10 mg tablets

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 one weight related comorbid condition (e.g. Hypertension, dyslipidaemia, type 2 diabetes)

22.10.2018

Levetiracetam injection 500mg/100ml, 1000 mg/100ml, and 1500mg/100ml. (Infussion bottle) (Additional dosage form)

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)

As adjunctive therapy in adult (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 epilepsyWith the condition: to be sold by retail on the prescription of Neurologist only.

Each film coated tablet contains:Ethinylestradiol IP.................30mcgDienogest IP………………..2mg

Indicated for use as an oral contraceptive and in the treatment of mild to moderate acne in women who seek oral contraception

30.10.2018

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: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)

For the treatment of acute lower back pain, osteoarthritis of shoulder, elbow, wrist, spine, hip, knee and ankle.

06.11.2018

Nepafenac Ophthalmic Suspension 0.3%w/v(Additional Indication)

Each ml contains:Nepafenac 3.0mg

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 Ophthalmologist only.

09.11.2018

Ibuprofen soft gelatine capsules 400mg.(New Dosage form)

Each soft gelatin capsule containsIbuprofen 400mg

For chronic arthritic disorder and painful musculoskeletal conditions.

20.11.2018

Fimasartan potassium trihydrate bulk drug and Fimasartan film coated tablets 30mg/60mg/120mg

For the treatment of mild hypertension

22.11.2018

Clobazam Oral suspension 2.5mg/ml(New Dosage form)

Each ml containsClobazam 2.5mg

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 Neurologist/ Psychiatrist only.

30.11.2018

Everolimus tablets 2.5 mg(Additional Indication)

Each tablets contains:Everolimus 2.5 mg

Treatment of patients with Progressive neuroendocrine tumors 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 Oncologist only.

05.12.2018

Clonazepam Mouth Dissolving tablets 0.25/0.5/1.0/2.0mg(New Dosage Form)

Each uncoated mouth dissolving tablet contains:Clonazepam 0.25/0.5/1.0/2.0 mg

Treatment of seizure disorders (Petit mal and its variant, 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 Psychiatrist only.

10.12.2018

Divalproex Sodium Oral Solution 250mg/5ml(Additional Strength)

Each 5 ml Contains:Divalproex 250mg

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.

21.12.2018

Ivermectin Cream 1.0% w/w(New Dosage form)

Each Gram Contains:Ivermectin 1.0% w/w

Treatment of inflammatory lesions of rosacea.With the condition: To be sold by retail on the prescription of Dermatologist only.

21.12.2018

Sacubitril/Valsartan (as sodium salt complex) and FDC of Sacubitril + Valartan 50 (24+26)/100 (49+51)/200 (97+103) mg film coated tablets

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

24.12.2018

Donepezil Hydrochloride Orally Disintegrating Strips(Additional dosage form)

Each Orally Disintegrating Strips Contains: Donepezil Hydrochloride 5/10 mg

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.

11.01.2019

Each Film coated tablets contains:Atorvastatin Calcium IP eq. to Atorvastatin + Vitamin D3 (Cholecalciferol) IP(10mg + 1000 IU) & (20mg + 1000 IU)

For the treatment of patients with hyperlipidemia.

22.01.2019

Tapentadol Hydrochloride capsule 50mg(New dosage form)

Each capsule contains:Tapentadol Hydrochloride 50mg

For relief of moderate to severe acute pain in adults 18 years of age or older.

30.01.2019

Fenspiride hydrochloride film coated extended release tablet 80 mg and Fenspiride hydrochloride bulk

1. Acute Rhinosinusitis2. Moderate persistent asthma as an add-on therapy

04.02.2019

Bilastine tablets 20 mg and Bilastine Bulk

For symptomatic treatment of allergic rhino-conjuctivitis (seasonal and perennial) and utricaria in adults

06.02.2019

Iguratimod film coated tablets 25mg and Iguratimod Bulk

For the treatment of active rheumatoid arthritis symptoms

18.02.2019

Midodrine Hydrochloride tablet 2.5mg, 5mg and 10mg(Additional strength)

Each tablet contains: Midodrine Hydrochloride 2.5mg, 5mg and 10mg

It is indicated in the treatment of symptomatic orthostatic hypotension.With the condition:-To be sold by retail on the prescription of Cardiologists only.

20.02.2019

Ribociclib film coated tablet 200mg(Additional indication)

Ribociclib succinate 254.40mg eq. To Ribociclib 200mg

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.

13.03.2019

100

Each 1ml contains:Hydrocortisone Aceponate .......1.11mgGentamicin Sulphate IP.............1505 IUMiconazole Nitrate IP................15.1mgOily Suspension (For external use only)For Veterinary Use Only

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

19.03.201

101

Each capsule contains:Glycopyrrolate USP equivalent to Glycopyrronium..............................12.5mcgFormoterol Fumarate Dihydrate ….12mcgFor Inhalation

It is indicated for:-As a maintenance bronchodilator treatment to relieve symptoms in adults patients with chronic obstructive pulmonary disease (COPD)

19.03.2019

102

Fingolimod Capsules 0.5mg and Fingolimod hydrochloridebulk

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.

25.03.2019

103

Azacitidine for injection 150mg/vial(Additional strength)

Each vial contains:Azacitidine. 150mg Lyophilized powder for injection(for subcutaneous or Intravenous use)

For the treatment of adult patients with all subtypes of Myelodysplastic Syndrome.With the condition: to be sold by retail on the prescription of Oncologist only.

25.03.2019

104

Lenvatinib capsule 4mg/10mg(Additional Indication)

Each capsule contains:Lenvatinib mesylate 4.90mg eq. To Lenvatinib 4mg.,Lenvatinib mesylate 12.25 mg eq. To Lenvatinib 10mg.

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.

26.03.2019

105

Primidone tablet 50mg(Additional Strength)

Each uncoated tablet contains:Primidone USP 50mg

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 an Neurologist only.

15.04.2019

106

Paroxetine Hydrochloride IP Eq. to Paroxetine (as extended release) + Clonazepam (25mg+0.5mg & 12.5mg+0.5mg)(Additional Dosage form)

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)

It is indicated for the treatment of patients with Co-morbid depression and anxiety.

16.04.2019

107

Each Dispersible tablet contains:Abacavir Sulphate IP eq .to Abacavir ……………60mgLamivudine IP …………….30mg(Additional Dosage form)

In combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus (HIV) infection in children

23.04.2019

108

Each film coated tablet contains:Dolutegravir Sodium Eq. to Dolutegravir…………………50mgEmtricitabine IP……………. 200mgTenofovir Alafenamide Fumarate eq. toTenofovir Alafenamide……….25mg

Indicated for the management of Human Immunodeficiency Virus (HIV) infections in adults weighing more than 40kg.

23.04.2019

109

Remogliflozin etabonate bulk and Remogliflozin etabonate film coated tablets 100 mg

Indicated in adults aged 18 years and older with type2 diabetes mellitus to improve glycemic control as:-· Monotherapy when diet and exercise alone do not provide adequate glyceamic control.· Add on therapy with metformin, together with diet and exercise, when these do not provide adequate glyceamic control.

26.04.2019

110

Amisulpride orodispersible tablet 50/100/200/300/400mg(New dosage form)

Each uncoated Oro dispersible tablet contains:Amisulpride 50/100/200/300/400mg

For acute and chronic schizophrenic disorders, in which positive and negative symptoms are prominent, including patients characterised by predominant negative symptoms.With the condition: To be sold by retail on the prescription of a Psychiatrist o

111

Progesterone solution for Injection 25mg/1.119ml vial (Add. Dosage form and add. route of administration)

Each vial (1.119 ml) contains:Progesterone 25mg (22.35mg/ml)(For subcutaneous or intramuscular use only)

It is indicated in adults for luteal support as part of an Assisted Reproductive Technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations.With the condition: To be sold by retail on the prescription of Gynaecologists only.

17.05.2019

112

Concentrate of Proteolytic enzyme enriched in Bromelain topical gel

Indicated for removal of eschar in adults with deep partial-and full-thickness thermal burns

17.05.2019

113

Each uncoated tablet contains :Perindopril Erbumine BP ……4mgIndapamide IP .......1.25mgAmlodipine Besilate IP …...5mg

For treatment of moderate to severe hypertension

20.05.2019

114

Eye Drops containsAlcaftadine ….. 0.25%w/vKetorolac Tromethamine ….0.4%w/v

For the treatment of ocular itching and other symptomatic associated allergic conjunctivitis.

21.05.2019

115

Azilsartan medoxomil tablet 20/40/80mg(Additional lower Strength)

Each uncoated tablet contains:Azilsartan Kamedoxomil equivalent to Azilsartan medoxomil 20/40/80mg

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.

27.05.2019

116

Everolimus Tablet 0.25mg/0.5mg/0.75mg/1.0mg(Additional indication)

Each film coated tablet contains:Everolimus 0.25mg/0.5mg/0.75mg/1.0mg

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 Cardiologist only.

27.05.2019

117

Each tablet containsSulfamethaxazole IP ….800mgTrimethoprim IP ….160mgIsoniazid IP ….300mgPyridoxine Hydrochloride IP…..25mg

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.

28.05.2019

118

Diclofenac sodium 2% Topical Solution(New route of administration)

Each 1 gram of solution contains: Diclofenac sodium 20mg

For the treatment of pain of osteoarthritis of the knees.

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

It is indicated for treatment of patients with uncontrolled essential hypertension and stable ischemic heart disease

04.06.2019

120

Menotrophin injection 600 IU/ml, 1 ml & 2 ml multi dose vial (Highly purified)

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 undegoing controlled ovarian hyperstimulation to induce the development of multiple follicles for Assisted Reproductive Technologies (ART).Hypogonadotropic hypogonadism in men

04.06.2019

121

Artesunate for injection 120mg with phosphate buffer 0.3M(Additional strength)

Each combi pack contains:a) Artesunate for injection 120mgEach vial contains:Artesunate IP 120mgb) Phosphate Buffer 0.3M (12ml)Each ampoule contains:Anhydrous Disodium Hydrogen Phosphate BP 4.0% w/vPotassium dihydrogen phosphate BP 0.2% w/v

Indicated for the treatment of severe falciparum malaria in areas where there is evidence of quinine resistance

26.06.2019

122

Injection For (Veterinary Use)Each ml ContainsBuparvaquone …..50mgFurosemide IP .…55mgSorbitan mono oleate BP …..100mg(As preservative)Oil base ……q.s.

For the treatment of theileriosis (east coast fever) particularly for advanced cases with pulmonary oedema.

27.06.2019

123

Dry Powder For InhalationEach Capsule Contains:Glycopyrronium (As Glycopyrrolate USP) …..25mcgFormoterol Fumarate Dihydrate .…12mcg

Indicated as a maintenance bronchodilator treatment to relieve symptoms in patients with chronic obstructive pulmonary disease(COPD)

28.06.2019

124

Rifapentine 150mg film coated tablet

“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”

08.07.2019

125

Each Film Coated Tablet contains:Azilsartan Kamedoxomil eq. To Azilsartan Medoxomil.........................40mgChlorthalidone IP …............6.25mg(In additional strength)

For the treatment of mild to moderate hypertension.

09.07.2019

126

Each Film Coated Tablet contains:Tadalafil IP + Dapoxetine Hydrochloride IP Eq. To Dapoxetine (20mg + 60mg, 20mg + 30mg & 10mg + 30mg)

For the treatment of co-existing Erectile Dysfunction and Premature Ejaculation in men 18 to 64 years of age.

23.07.2019

127

Tranexamic acid injection IP 100mg/ml(Additional Indication)

Each ml contains:Tranexamic acid IP 100 mg/ml

Indicated for short term use in prophylaxis and treatment in patients at high risk of per-and post-operative hemorrhage following: a) Prostatectomy.b) Conisation of the cervix.c) Surgical procedures and dental extractions in hemophiliacs

26.07.2019

128

Rivaroxaban tablets 2.5mg(Add. Indication)

Rivaroxaban tablets 2.5mg

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.

30.07.2019

129

Olaparib 100 mg and 150 mg tablet(Additional Indication)

Olaparib 100 mg and 150 mg tablet

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 chemotherapyWith the condition:-To be sold by retail on the prescription of Oncologist only.

30.07.2019

130

Tapentadol Hydrochloride 25.000 milligram (mg) Capsules(Additional Lower Strength)

Tapentadol Hydrochloride 25.000 milligram (mg) Capsules

For relief of moderate to severe acute pain in adults 18 years of age or older

131

Each orodispersible Tablets contains:Streptococcus faecalis T-110 JPC.....30 millionClostridium butyricum TO-A.............2 millionBacillus mesentericus TO-A JPC........1 millionLactic acid bacillus .......50 million (lactobacillus sporogenes)(In additional dosage form)

For restoration of intestinal microflora

30.07.2019

132

Leuprolide 22.50mg depot Injection Powder for prolonged-release suspension for injection (Depot injection for I.M. use only)(Add. strength)

Each vial contains :Leuprolide acetate 22.5mg

Treatment of advanced Prostatic cancer.With the condition:-To be sold by retail on the prescription of Oncologist only.

07.08.2019

133

Clobazam Tablets IP 2.5mg & 7.5mg(Add. lower strength).

Each tablet contains:Clobazam 2.5mg & 7.5mg

As an adjunctive therapy in patients with refractory epilepsy.With the condition:-To be sold by retail on the prescription of Neurologist/ Psychiatrist only.

07.08.2019

134

Sildenafil for oral suspension 10mg/ml(Add. Indication)

Each ml of reconstituted suspension contains:Sildenafil citrate IP equivalent to Sildenafil 10mg

For the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delayed clinical worsening. With the condition:-To be sold by retail on the prescription of Cardiologist only.

09.08-2019

135

FDC of Bictegravir, Emtricitabine and Tenofovir alafenamide 50mg/200mg/25mg tablets

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

09.08-2019

136

Levomilnacipran ER capsules 20mg/40mg/80mg/120mg

For treatment of major depressive disorder

13.08.2019

137

Each Film Coated Tablet contains:Remogliflozin Etabonate + Metformin Hydrochloride IP (100mg + 500mg & 100mg + 1000mg)

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 alone2. In patients already being treated with the combination of remogliflozin and metformin as separate tablets.

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)

For the treatment of upper respiratory tract infections (URTI) and uncomplicated skin and soft tissue infections.

14.08.2019

139

Pantoprazole dual-release gastro- resistant tablet 80mg(New Dosage form)

Each dual-release gastro- resistant tablet contains:Pantoprazole sodium equivalent to Pantoprazole 80mg

For the treatment of moderate to severe refractory Gastro-oesophageal reflux disease (GERD) for 4 weeks only.

02.09.2019

140

Pirfenidone tablet 400 mg(Add. Strength)

Each film coated tablet contains:Pirfenidone 400mg

For the treatment of idiopathic pulmonary fibrosis.With the condition:-To be sold by retail on the prescription of Pulmonologist only.

02.09.2019

141

Olopatadine HCI ophthalmic solution 0.7% w/v(Add. strength)

Each ml contains:Olopatadine HCI 0.7% w/vBenzalkonium chloride 0.015%w/v

For the treatment of ocular itching associated with allergic conjunctivitis.With the condition:-To be sold by retail on the prescription of Ophthalmologist only.

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

Surface disinfectant for persistent disinfection of all inanimate surfaces

09.09.2019

143

Safinamide methane sulphonate bulk drug and Safinamide tablets 50, 100mg

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.

09.09.2019

144

Bosutinib bulk and Bosutinib tablets 100mg,

For the treatmnet 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.

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

Surface disinfectant for persistent disinfection of all inanimate surfaces (Against pathogens as annexed)

09.09.2019

146

Ibrutinib hard gelatin capsule 140mg(Add. indication)

Each capsule contains:Ibrutinib 140mg

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 Oncologist only.

11.09.2019

147

Ibrutinib hard gelatin capsule 140mg(Add. indication)

Each capsule contains:Ibrutinib 140mg

For the treatment of patients with Waldenstrom's macroglobulinemia

11.09.2019

148

Each Film Coated Tablets contains:Saxagliptin Hydrochloride 5.95mg Eq. To Saxagliptin........................5mgDapagliflozin Propanediol monohydrate 12.3mg Eq. To Dapagliflozin.........10mg

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 type1 diabetes.Not to be used for the treatment of diabetic ketoacidosis.

24.09.2019

149

Droxidopa bulk drug and Droxidopa capsules 200mg/300mg

For the treatment of orthostatic dizziness, light headedness 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.

24.09.2019

150

Desonide Ointment 0.05%(Add. Dosage form)

Desonide topical ointment 0.05%

for sub-acute to chronic steroid responsive dermatoses.

26.09.2019

Published by Fedley Healthcare on 3 September 2025

Complete list of CDSCO approved drugs in India

Complete list of CDSCO approved drugs in India

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