Details for New Drug Application (NDA): 078438
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NDA 078438 describes TRANDOLAPRIL, which is a drug marketed by Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Invagen Pharms, Lupin, Norvium Bioscience, Teva Pharms, Watson Labs, and Glenmark Pharms Ltd, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the TRANDOLAPRIL profile page.
The generic ingredient in TRANDOLAPRIL is trandolapril; verapamil hydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trandolapril; verapamil hydrochloride profile page.
The generic ingredient in TRANDOLAPRIL is trandolapril; verapamil hydrochloride. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trandolapril; verapamil hydrochloride profile page.
Summary for 078438
| Tradename: | TRANDOLAPRIL |
| Applicant: | Aurobindo Pharma |
| Ingredient: | trandolapril |
| Patents: | 0 |
Pharmacology for NDA: 078438
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Suppliers and Packaging for NDA: 078438
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRANDOLAPRIL | trandolapril | TABLET;ORAL | 078438 | ANDA | Rising Pharma Holdings, Inc. | 57237-089 | 57237-089-01 | 100 TABLET in 1 BOTTLE (57237-089-01) |
| TRANDOLAPRIL | trandolapril | TABLET;ORAL | 078438 | ANDA | Rising Pharma Holdings, Inc. | 57237-090 | 57237-090-01 | 100 TABLET in 1 BOTTLE (57237-090-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jun 12, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jun 12, 2007 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 4MG | ||||
| Approval Date: | Jun 12, 2007 | TE: | AB | RLD: | No | ||||
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