Details for New Drug Application (NDA): 079135
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NDA 079135 describes TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE profile page.
The generic ingredient in TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE 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 AND VERAPAMIL HYDROCHLORIDE 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 079135
| Tradename: | TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE |
| Applicant: | Glenmark Pharms Ltd |
| Ingredient: | trandolapril; verapamil hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 079135
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | trandolapril; verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079135 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-294 | 68462-294-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-01) |
| TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE | trandolapril; verapamil hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 079135 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-294 | 68462-294-10 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-294-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2MG;180MG | ||||
| Approval Date: | May 26, 2010 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 2MG;240MG | ||||
| Approval Date: | May 26, 2010 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 4MG;240MG | ||||
| Approval Date: | May 5, 2010 | TE: | RLD: | No | |||||
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