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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Argus Health
Chinese Patent Office
McKinsey
Novartis
Medtronic
Healthtrust
Colorcon
Cipla

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075480

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NDA 075480 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 Usa, 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-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. Eleven suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

Summary for 075480

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075480

Suppliers and Packaging for NDA: 075480

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075480 ANDA Mylan Pharmaceuticals Inc. 0378-1051 0378-1051-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-1051-01)
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075480 ANDA Mylan Pharmaceuticals Inc. 0378-1052 0378-1052-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-1052-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 22, 2000TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Aug 22, 2000TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Aug 22, 2000TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

US Army
Colorcon
Teva
Citi
Harvard Business School
Cipla
Argus Health
Accenture
Boehringer Ingelheim
Cantor Fitzgerald

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