DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 203171
» See Plans and Pricing
NDA 203171 describes TELMISARTAN, which is a drug marketed by Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Celltrion, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Micro Labs, Mylan, Prinston Inc, Sandoz Inc, Torrent, Zydus Pharms, Lupin Ltd, and Macleods Pharms Ltd, and is included in twenty-nine NDAs. It is available from twenty-one 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 203171
| Tradename: | TELMISARTAN |
| Applicant: | Torrent |
| Ingredient: | telmisartan |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203171
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 203171
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TELMISARTAN | telmisartan | TABLET;ORAL | 203171 | ANDA | Torrent Pharmaceuticals Limited | 13668-156 | 13668-156-01 | 100 TABLET in 1 BOTTLE (13668-156-01) |
| TELMISARTAN | telmisartan | TABLET;ORAL | 203171 | ANDA | Torrent Pharmaceuticals Limited | 13668-156 | 13668-156-30 | 30 TABLET in 1 BOTTLE (13668-156-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jul 7, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Jul 7, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Jul 7, 2014 | TE: | AB | RLD: | No | ||||
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