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Serving leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Fish and Richardson
US Department of Justice
Cantor Fitzgerald

Generated: October 19, 2017

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 Watson Labs, Sandoz Inc, Sandoz, Sun Pharm Inds Ltd, Taro, Krka Dd Novo Mesto, Mylan, Apotex, Teva, Ivax Sub Teva Pharms, Apothecon, Wockhardt Usa, Dr Reddys Labs Ltd, Upsher-smith Labs, G And W Labs Inc, Apotex Inc, and Taro Pharm Inds, and is included in twenty-three NDAs. It is available from thirty-seven 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. Ten suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

Summary for NDA: 075657

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075657

Suppliers and Packaging for NDA: 075657

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
enalapril maleate
TABLET;ORAL 075657 ANDA Blenheim Pharmacal, Inc. 10544-195 10544-195-90 90 TABLET in 1 BOTTLE (10544-195-90)
enalapril maleate
TABLET;ORAL 075657 ANDA Blenheim Pharmacal, Inc. 10544-293 10544-293-30 30 TABLET in 1 BOTTLE (10544-293-30)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Queensland Health
Johnson and Johnson
Farmers Insurance
Boehringer Ingelheim

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