Details for New Drug Application (NDA): 076820
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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 076820
Tradename: | BENAZEPRIL HYDROCHLORIDE |
Applicant: | Amneal Pharms |
Ingredient: | benazepril hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076820
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Decreased Blood Pressure |
Suppliers and Packaging for NDA: 076820
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076820 | ANDA | AvPAK | 50268-109 | 50268-109-15 | 50 BLISTER PACK in 1 BOX (50268-109-15) / 1 TABLET in 1 BLISTER PACK (50268-109-11) |
BENAZEPRIL HYDROCHLORIDE | benazepril hydrochloride | TABLET;ORAL | 076820 | ANDA | AvPAK | 50268-110 | 50268-110-15 | 50 BLISTER PACK in 1 BOX (50268-110-15) / 1 TABLET in 1 BLISTER PACK (50268-110-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Feb 3, 2006 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Feb 3, 2006 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
Approval Date: | Feb 3, 2006 | TE: | AB | RLD: | No |
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