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QuintilesIMS
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Argus Health
Cipla
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Dow
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Merck

Generated: February 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075496

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NDA 075496 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 075496
Tradename:ENALAPRIL MALEATE
Applicant:Sandoz Inc
Ingredient:enalapril maleate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075496
Medical Subject Heading (MeSH) Categories for 075496
Suppliers and Packaging for NDA: 075496
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075496 ANDA Northstar RxLLC 16714-442 N 16714-442-01
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075496 ANDA Northstar RxLLC 16714-442 N 16714-442-02

Profile for product number 001

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

Profile for product number 002

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

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McKinsey
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