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Generated: April 20, 2018

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 Apotex Inc, Dr Reddys Labs Ltd, G And W Labs Inc, Ivax Sub Teva Pharms, Mylan, Taro Pharm Inds, and Upsher-smith Labs, and is included in seven NDAs. It is available from nine 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. Eleven suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
Summary for 075909
Tradename:ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Applicant:Dr Reddys Labs Ltd
Ingredient:enalapril maleate; hydrochlorothiazide
Patents:0
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 AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075909 ANDA Dr. Reddy's Laboratories Limited 55111-133 N 55111-133-01
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075909 ANDA Dr. Reddy's Laboratories Limited 55111-133 N 55111-133-10

Profile for product number 001

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

Profile for product number 002

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

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