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Serving leading biopharmaceutical companies globally:

Accenture
Julphar
Medtronic
Cipla
Queensland Health
Merck
Fuji
Teva
Express Scripts
Federal Trade Commission

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075556

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NDA 075556 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 075556
Tradename:ENALAPRIL MALEATE
Applicant:Sun Pharm Inds Ltd
Ingredient:enalapril maleate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075556
Medical Subject Heading (MeSH) Categories for 075556
Suppliers and Packaging for NDA: 075556
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075556 ANDA Ranbaxy Pharmaceuticals Inc. 63304-522 63304-522-01 100 TABLET in 1 BOTTLE (63304-522-01)
ENALAPRIL MALEATE enalapril maleate TABLET;ORAL 075556 ANDA Ranbaxy Pharmaceuticals Inc. 63304-522 63304-522-10 1000 TABLET in 1 BOTTLE (63304-522-10)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength2.5MG
Approval Date:Aug 22, 2000TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Aug 22, 2000TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength10MG
Approval Date:Aug 22, 2000TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
AstraZeneca
Johnson and Johnson
Fuji
Boehringer Ingelheim
Federal Trade Commission
Healthtrust
Cantor Fitzgerald
Teva

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