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Generated: April 27, 2017

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Details for New Drug Application (NDA): 078212

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NDA 078212 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-two 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: 078212

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078212

Suppliers and Packaging for NDA: 078212

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
benazepril hydrochloride
TABLET;ORAL 078212 ANDA PD-Rx Pharmaceuticals, Inc. 43063-748 43063-748-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-748-30)
benazepril hydrochloride
TABLET;ORAL 078212 ANDA Aurobindo Pharma Limited 65862-116 65862-116-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-116-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 22, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 22, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:May 22, 2008TE:ABRLD:No

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