Details for New Drug Application (NDA): 076267
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The generic ingredient in BENAZEPRIL HYDROCHLORIDE is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.
Summary for 076267
Tradename: | BENAZEPRIL HYDROCHLORIDE |
Applicant: | Heritage Pharma |
Ingredient: | benazepril hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076267
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 076267
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076267 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-749 | 23155-749-01 | 100 TABLET in 1 BOTTLE (23155-749-01) |
BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076267 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-749 | 23155-749-05 | 500 TABLET in 1 BOTTLE (23155-749-05) |
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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