Details for New Drug Application (NDA): 203325
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NDA 203325 describes TELMISARTAN, which is a drug marketed by Alembic, Amneal Pharms, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd V, Hisun Pharm Hangzhou, Inventia, Jubilant Generics, Mankind Pharma, Micro Labs, Mylan, Prinston Inc, Sandoz, Torrent, Zydus Pharms, Lupin Ltd, Macleods Pharms Ltd, and Natco, and is included in thirty NDAs. It is available from twenty-six 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 203325
| Tradename: | TELMISARTAN |
| Applicant: | Zydus Pharms |
| Ingredient: | telmisartan |
| Patents: | 0 |
Pharmacology for NDA: 203325
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 203325
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TELMISARTAN | telmisartan | TABLET;ORAL | 203325 | ANDA | Zydus Lifesciences Limited | 65841-804 | 65841-804-01 | 100 TABLET in 1 BOTTLE (65841-804-01) |
| TELMISARTAN | telmisartan | TABLET;ORAL | 203325 | ANDA | Zydus Lifesciences Limited | 65841-804 | 65841-804-05 | 500 TABLET in 1 BOTTLE (65841-804-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Aug 26, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Aug 26, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Aug 26, 2014 | TE: | AB | RLD: | No | ||||
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