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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Deloitte
Covington
Mallinckrodt
Merck
Fuji
Johnson and Johnson
Farmers Insurance
Accenture

Generated: April 24, 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 thirty-eight suppliers. Additional details are available on the GEMFIBROZIL profile page.

The generic ingredient in GEMFIBROZIL is gemfibrozil. Thirty-nine 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 24658-260-90
GEMFIBROZIL gemfibrozil TABLET;ORAL 078012 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-260 N 24658-260-30

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
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Federal Trade Commission
Dow
Express Scripts
Argus Health
US Department of Justice
McKinsey
Citi

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