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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Medtronic
Merck
Healthtrust
Johnson and Johnson
Mallinckrodt
US Department of Justice
Express Scripts
Fuji

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075624

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NDA 075624 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 six 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. Eight suppliers are listed for this compound. Additional details are available on the enalapril maleate; hydrochlorothiazide profile page.
Summary for 075624
Tradename:ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
Applicant:Mylan
Ingredient:enalapril maleate; hydrochlorothiazide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075624
Suppliers and Packaging for NDA: 075624
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075624 ANDA Mylan Pharmaceuticals Inc. 0378-0712 N 0378-0712-01
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE enalapril maleate; hydrochlorothiazide TABLET;ORAL 075624 ANDA Mylan Pharmaceuticals Inc. 0378-0723 N 0378-0723-01

Profile for product number 001

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

Profile for product number 002

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

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Teva
Baxter
Federal Trade Commission
Fish and Richardson
Boehringer Ingelheim
Chubb
Queensland Health
Covington

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