DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203867
NDA 203867 describes TELMISARTAN, which is a drug marketed by Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd V, Inventia Hlthcare, Jubilant Generics, Micro Labs, Mylan Pharms Inc, Prinston Inc, Sandoz Inc, Torrent Pharms Ltd, Watson Labs, Zydus Pharms Usa Inc, Lupin Ltd, and Macleods Pharms Ltd, and is included in twenty-seven NDAs. It is available from twenty suppliers. Additional details are available on the TELMISARTAN profile page.
The generic ingredient in TELMISARTAN is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
The generic ingredient in TELMISARTAN is hydrochlorothiazide; telmisartan. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 203867
| Tradename: | TELMISARTAN |
| Applicant: | Sandoz Inc |
| Ingredient: | telmisartan |
| Patents: | 0 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203867
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 203867
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TELMISARTAN | telmisartan | TABLET;ORAL | 203867 | ANDA | Sandoz Inc | 0781-5372 | N | 0781-5372-06 |
| TELMISARTAN | telmisartan | TABLET;ORAL | 203867 | ANDA | Sandoz Inc | 0781-5372 | N | 0781-5372-64 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Nov 3, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Nov 3, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Nov 3, 2014 | TE: | AB | RLD: | No | ||||
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