Details for New Drug Application (NDA): 076118
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NDA 076118 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-three 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.
Summary for 076118
| Tradename: | BENAZEPRIL HYDROCHLORIDE |
| Applicant: | Prinston Inc |
| Ingredient: | benazepril hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 076118
| Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
| Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 076118
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076118 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-677 | 43063-677-30 | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-677-30) |
| BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076118 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-677 | 43063-677-90 | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-677-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 11, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Feb 11, 2004 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Feb 11, 2004 | TE: | AB | RLD: | No | ||||
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