Details for New Drug Application (NDA): 078212
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NDA 078212 describes BENAZEPRIL HYDROCHLORIDE, which is a drug marketed by Amneal Pharms, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Corepharma, Genpharm, Heritage Pharma, Prinston Inc, Rising, Sun Pharm Inds Ltd, Teva, Zydus Lifesciences, Apotex, Aurobindo Pharma Usa, Mylan Pharms Inc, and Sandoz, and is included in nineteen NDAs. It is available from twenty-six suppliers. Additional details are available on the BENAZEPRIL HYDROCHLORIDE profile page.
The generic ingredient in BENAZEPRIL HYDROCHLORIDE is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.
The generic ingredient in BENAZEPRIL HYDROCHLORIDE is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.
Summary for 078212
| Tradename: | BENAZEPRIL HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma |
| Ingredient: | benazepril hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078212
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 078212
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 078212 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-748 | 43063-748-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-748-30) |
| BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 078212 | ANDA | A-S Medication Solutions | 50090-3359 | 50090-3359-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-3359-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 22, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | May 22, 2008 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | May 22, 2008 | TE: | AB | RLD: | No | ||||
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