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Baxter
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Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076688

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NDA 076688 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 eight 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. Ten suppliers are listed for this compound. Additional details are available on the benazepril hydrochloride; hydrochlorothiazide profile page.
Summary for 076688
Tradename:BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Applicant:Mylan
Ingredient:benazepril hydrochloride; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076688
Suppliers and Packaging for NDA: 076688
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 076688 ANDA Mylan Pharmaceuticals Inc. 0378-4725 N 0378-4725-01
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE benazepril hydrochloride; hydrochlorothiazide TABLET;ORAL 076688 ANDA Mylan Pharmaceuticals Inc. 0378-4735 N 0378-4735-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;6.25MG
Approval Date:Feb 11, 2004TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;12.5MG
Approval Date:Feb 11, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG;12.5MG
Approval Date:Feb 11, 2004TE:ABRLD:No

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