Details for New Drug Application (NDA): 076631
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NDA 076631 describes BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Apotex, Aurobindo Pharma Usa, Mylan Pharms Inc, Sandoz, and Sun Pharm Inds Ltd, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE profile page.
The generic ingredient in BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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.
The generic ingredient in BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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 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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