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Details for New Drug Application (NDA): 076486

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NDA 076486 describes ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Dr Reddys Labs Ltd, Upsher-smith Labs, Mylan, G And W Labs Inc, Ivax Sub Teva Pharms, Apotex Inc, and Taro Pharm Inds, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE is enalapril maleate; hydrochlorothiazide. There are twenty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

Summary for NDA: 076486

Tradename:
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Applicant:
Apotex Inc
Ingredient:
enalapril maleate; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 076486

Suppliers and Packaging for NDA: 076486

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
enalapril maleate; hydrochlorothiazide
TABLET;ORAL 076486 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-823 49999-823-30 30 TABLET in 1 BOTTLE (49999-823-30)
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
enalapril maleate; hydrochlorothiazide
TABLET;ORAL 076486 ANDA Lake Erie Medical DBA Quality Care Products LLC 49999-823 49999-823-60 60 TABLET in 1 BOTTLE (49999-823-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;12.5MG
Approval Date:Oct 27, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;25MG
Approval Date:Oct 27, 2004TE:ABRLD:No


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