Details for New Drug Application (NDA): 076118
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The generic ingredient in BENAZEPRIL HYDROCHLORIDE is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Seven 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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