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US Army
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QuintilesIMS

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075657

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NDA 075657 describes ENALAPRIL MALEATE, which is a drug marketed by Apotex, Apothecon, Ivax Sub Teva Pharms, Krka Dd Novo Mesto, Mylan, Sandoz, Sandoz Inc, Sun Pharm Inds Ltd, Taro, Teva, Watson Labs, Wockhardt Ltd, Apotex Inc, Dr Reddys Labs Ltd, G And W Labs Inc, Taro Pharm Inds, and Upsher-smith Labs, and is included in twenty-three NDAs. It is available from thirty-six suppliers. Additional details are available on the ENALAPRIL MALEATE profile page.

The generic ingredient in ENALAPRIL MALEATE 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 075657
Tradename:ENALAPRIL MALEATE
Applicant:Taro
Ingredient:enalapril maleate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075657
Medical Subject Heading (MeSH) Categories for 075657
Suppliers and Packaging for NDA: 075657
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075657 ANDA Blenheim Pharmacal, Inc. 10544-195 E 10544-195-90
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075657 ANDA Blenheim Pharmacal, Inc. 10544-293 E 10544-293-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jan 23, 2001TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 23, 2001TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jan 23, 2001TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Mallinckrodt
Medtronic
Merck
Chubb
Dow
Citi
Fish and Richardson
Queensland Health

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