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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 078794


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NDA 078794 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 four 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. Eight suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.
Summary for 078794
Tradename:BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Applicant:Apotex
Ingredient:benazepril hydrochloride; hydrochlorothiazide
Patents:0
Pharmacology for NDA: 078794
Mechanism of ActionAngiotensin-converting Enzyme Inhibitors
Physiological EffectDecreased Blood Pressure
Increased Diuresis
Suppliers and Packaging for NDA: 078794
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 078794 ANDA Apotex Corp. 60505-0261 60505-0261-1 100 TABLET in 1 BOTTLE (60505-0261-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;6.25MG
Approval Date:Aug 21, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;12.5MG
Approval Date:Aug 21, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG;12.5MG
Approval Date:Aug 21, 2014TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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