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Generated: December 13, 2017

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 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 075496

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

Pharmacology for NDA: 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 16714-442-01 100 TABLET in 1 BOTTLE (16714-442-01)
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075496 ANDA Northstar RxLLC 16714-442 16714-442-02 1000 TABLET in 1 BOTTLE (16714-442-02)

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


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Serving leading biopharmaceutical companies globally:

Covington
Accenture
Dow
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Cantor Fitzgerald
Chinese Patent Office
Healthtrust
Merck
Julphar
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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