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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077483

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NDA 077483 describes BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Actavis Labs Fl Inc, Apotex Inc, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Sandoz, and Sun Pharm Inds Ltd, and is included in seven NDAs. It is available from ten 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. Twelve suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.

Summary for 077483

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 077483

Suppliers and Packaging for NDA: 077483

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 077483 ANDA Ranbaxy Pharmaceuticals Inc. 63304-154 63304-154-01 100 TABLET, COATED in 1 BOTTLE (63304-154-01)
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 077483 ANDA Ranbaxy Pharmaceuticals Inc. 63304-154 63304-154-10 1000 TABLET, COATED in 1 BOTTLE (63304-154-10)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG;6.25MG
Approval Date:Sep 8, 2005TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG;12.5MG
Approval Date:Sep 8, 2005TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG;12.5MG
Approval Date:Sep 8, 2005TE:RLD:No


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