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Generated: April 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075909

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NDA 075909 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 eight 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. Ten suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

Summary for NDA: 075909

Formulation / Manufacturing:see details

Pharmacology for NDA: 075909

Suppliers and Packaging for NDA: 075909

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
enalapril maleate; hydrochlorothiazide
TABLET;ORAL 075909 ANDA Dr. Reddy's Laboratories Limited 55111-133 55111-133-01 100 TABLET in 1 BOTTLE (55111-133-01)
enalapril maleate; hydrochlorothiazide
TABLET;ORAL 075909 ANDA Dr. Reddy's Laboratories Limited 55111-133 55111-133-10 1000 TABLET in 1 BOTTLE (55111-133-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;12.5MG
Approval Date:Oct 15, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;25MG
Approval Date:Oct 15, 2001TE:ABRLD:No

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