Details for New Drug Application (NDA): 078710
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NDA 078710 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, Macleods Pharms Ltd, Mankind Pharma, Micro Labs, Mylan, Prinston Inc, Sandoz, Torrent, Zydus Pharms, Lupin Ltd, and Natco, and is included in thirty-two NDAs. It is available from twenty-eight 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. Seven 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. Seven suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; telmisartan profile page.
Summary for 078710
| Tradename: | TELMISARTAN |
| Applicant: | Chartwell Rx |
| Ingredient: | telmisartan |
| Patents: | 0 |
Pharmacology for NDA: 078710
| Mechanism of Action | Angiotensin 2 Receptor Antagonists |
Suppliers and Packaging for NDA: 078710
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TELMISARTAN | telmisartan | TABLET;ORAL | 078710 | ANDA | Chartwell RX, LLC. | 62135-535 | 62135-535-30 | 30 TABLET in 1 BOTTLE (62135-535-30) |
| TELMISARTAN | telmisartan | TABLET;ORAL | 078710 | ANDA | Chartwell RX, LLC. | 62135-536 | 62135-536-30 | 30 TABLET in 1 BOTTLE (62135-536-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jan 8, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Jan 8, 2014 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 80MG | ||||
| Approval Date: | Jan 8, 2014 | TE: | AB | RLD: | No | ||||
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