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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Queensland Health
Daiichi Sankyo

Generated: February 17, 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 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 075624
Ingredient:enalapril maleate; hydrochlorothiazide
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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