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Generated: November 16, 2018

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Details for New Drug Application (NDA): 076118

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NDA 076118 describes BENAZEPRIL HYDROCHLORIDE, which is a drug marketed by Actavis Labs Fl Inc, Amneal Pharms, Apotex Inc, Aurobindo Pharma, Casi Pharms Inc, Genpharm, Ivax Sub Teva Pharms, Mylan, Prinston Inc, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Mylan Pharms Inc, and Sandoz, and is included in nineteen NDAs. It is available from thirty-eight 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. Ten 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 076118
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 Blenheim Pharmacal, Inc. 10544-561 10544-561-30 30 TABLET, FILM COATED in 1 BOTTLE (10544-561-30)
BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride TABLET;ORAL 076118 ANDA Blenheim Pharmacal, Inc. 10544-561 10544-561-90 90 TABLET, FILM COATED in 1 BOTTLE (10544-561-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 11, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Feb 11, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Feb 11, 2004TE:ABRLD:No

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