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Farmers Insurance
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Chinese Patent Office
Harvard Business School
Dow
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Baxter
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078848

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NDA 078848 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-four 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 078848
Tradename:BENAZEPRIL HYDROCHLORIDE
Applicant:Zydus Pharms Usa
Ingredient:benazepril hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078848
Suppliers and Packaging for NDA: 078848
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride TABLET;ORAL 078848 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-169 N 68382-169-01
BENAZEPRIL HYDROCHLORIDE benazepril hydrochloride TABLET;ORAL 078848 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-169 N 68382-169-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 23, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 23, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:May 23, 2008TE:ABRLD:No

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