Details for New Drug Application (NDA): 076631
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The generic ingredient in BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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 076631
Tradename: | BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE |
Applicant: | Sandoz |
Ingredient: | benazepril hydrochloride; hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 076631
Mechanism of Action | Angiotensin-converting Enzyme Inhibitors |
Physiological Effect | Decreased Blood Pressure Increased Diuresis |
Suppliers and Packaging for NDA: 076631
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | benazepril hydrochloride; hydrochlorothiazide | TABLET;ORAL | 076631 | ANDA | Sandoz Inc | 0185-0211 | 0185-0211-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0185-0211-01) |
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | benazepril hydrochloride; hydrochlorothiazide | TABLET;ORAL | 076631 | ANDA | Sandoz Inc | 0185-0236 | 0185-0236-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0185-0236-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;6.25MG | ||||
Approval Date: | Feb 11, 2004 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;12.5MG | ||||
Approval Date: | Feb 11, 2004 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG;12.5MG | ||||
Approval Date: | Feb 11, 2004 | TE: | AB | RLD: | No |
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