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Details for New Drug Application (NDA): 076820

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NDA 076820 describes BENAZEPRIL HYDROCHLORIDE, which is a drug marketed by Sandoz, Teva, Aurobindo Pharma, Prinston Inc, Amneal Pharms Llc, Apotex Inc, Mylan, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Zydus Pharms Usa, Actavis Labs Fl Inc, Genpharm, and Mylan Pharms Inc, and is included in nineteen NDAs. It is available from forty suppliers. Additional details are available on the BENAZEPRIL HYDROCHLORIDE profile page.

The generic ingredient in BENAZEPRIL HYDROCHLORIDE is benazepril hydrochloride; hydrochlorothiazide. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.

Summary for NDA: 076820

Amneal Pharms Llc
benazepril hydrochloride
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 076820

Suppliers and Packaging for NDA: 076820

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
benazepril hydrochloride
TABLET;ORAL 076820 ANDA Major Pharmaceuticals 0904-6189 0904-6189-40 500 TABLET in 1 BOTTLE (0904-6189-40)
benazepril hydrochloride
TABLET;ORAL 076820 ANDA Major Pharmaceuticals 0904-6190 0904-6190-40 500 TABLET in 1 BOTTLE (0904-6190-40)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 3, 2006TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 3, 2006TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Feb 3, 2006TE:ABRLD:No

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