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Serving leading biopharmaceutical companies globally:

Dow
Farmers Insurance
Julphar
Cantor Fitzgerald
Johnson and Johnson
Citi
Healthtrust
QuintilesIMS
US Department of Justice
Harvard Business School

Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078012

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NDA 078012 describes GEMFIBROZIL, which is a drug marketed by Mylan, Purepac Pharm, Apotex, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Caribe Holdings, Chartwell Molecules, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Sun Pharm Inds Inc, Teva, Watson Labs, and Yaopharma Co Ltd, and is included in eighteen NDAs. It is available from fifty-two suppliers. Additional details are available on the GEMFIBROZIL profile page.

The generic ingredient in GEMFIBROZIL is gemfibrozil. There are twenty drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.
Summary for 078012
Tradename:GEMFIBROZIL
Applicant:Caribe Holdings
Ingredient:gemfibrozil
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078012
Medical Subject Heading (MeSH) Categories for 078012
Suppliers and Packaging for NDA: 078012
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMFIBROZIL gemfibrozil TABLET;ORAL 078012 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-260 N 24658-260-18
GEMFIBROZIL gemfibrozil TABLET;ORAL 078012 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-260 N 24658-260-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Mar 26, 2007TE:ABRLD:No

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Chubb
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Cerilliant
Johnson and Johnson
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Daiichi Sankyo
Merck
Covington
Fish and Richardson

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