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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Express Scripts
Boehringer Ingelheim

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075788

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NDA 075788 describes ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Apotex Inc, Dr Reddys Labs Ltd, G And W Labs Inc, Ivax Sub Teva Pharms, Mylan, Taro Pharm Inds, and Upsher-smith Labs, and is included in seven NDAs. It is available from nine suppliers. Additional details are available on the ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE 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 075788

Formulation / Manufacturing:see details

Pharmacology for NDA: 075788

Suppliers and Packaging for NDA: 075788

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075788 ANDA Rebel Distributors Corp 21695-780 21695-780-30 30 TABLET in 1 BOTTLE (21695-780-30)
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075788 ANDA Taro Pharmaceuticals U.S.A., Inc. 51672-4045 51672-4045-1 100 TABLET in 1 BOTTLE (51672-4045-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;12.5MG
Approval Date:Sep 18, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;25MG
Approval Date:Sep 18, 2001TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

US Army
US Department of Justice
Chinese Patent Office

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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