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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075727

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NDA 075727 describes ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Dr Reddys Labs Ltd, Upsher-smith Labs, Mylan, G And W Labs Inc, Ivax Sub Teva Pharms, Apotex Inc, and Taro Pharm Inds, and is included in seven NDAs. It is available from eight 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. Ten suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.

Summary for NDA: 075727

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 075727

Suppliers and Packaging for NDA: 075727

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
enalapril maleate; hydrochlorothiazide
TABLET;ORAL 075727 ANDA G&W Laboratories, Inc. 0713-1044 0713-1044-01 100 TABLET in 1 BOTTLE (0713-1044-01)
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
enalapril maleate; hydrochlorothiazide
TABLET;ORAL 075727 ANDA G&W Laboratories, Inc. 0713-1052 0713-1052-01 100 TABLET in 1 BOTTLE (0713-1052-01)

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 500+ biopharmaceutical companies globally:

Deloitte
Merck
Moodys
Cerilliant
Argus Health
Farmers Insurance
Novartis
Covington
US Army
Colorcon

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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