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Serving leading biopharmaceutical companies globally:

Chubb
Covington
Julphar
Teva
Moodys
QuintilesIMS
Dow
McKinsey
US Army
Cipla

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075459

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NDA 075459 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 075459

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

Pharmacology for NDA: 075459

Suppliers and Packaging for NDA: 075459

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075459 ANDA Northstar RxLLC 16714-444 16714-444-01 100 TABLET in 1 BOTTLE (16714-444-01)
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075459 ANDA Northstar RxLLC 16714-444 16714-444-02 1000 TABLET in 1 BOTTLE (16714-444-02)

Summary for product number 001

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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 22, 2000TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Accenture
UBS
Baxter
Queensland Health
Harvard Business School
Julphar
Citi
McKesson
Daiichi Sankyo
Covington

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