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Mallinckrodt
Teva
US Army
Baxter
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Fuji
Fish and Richardson
Moodys
Argus Health
Chinese Patent Office

Generated: February 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075034

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NDA 075034 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 075034
Tradename:GEMFIBROZIL
Applicant:Apotex
Ingredient:gemfibrozil
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075034
Medical Subject Heading (MeSH) Categories for 075034
Suppliers and Packaging for NDA: 075034
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMFIBROZIL gemfibrozil TABLET;ORAL 075034 ANDA Aidarex Pharmaceuticals LLC 33261-146 N 33261-146-30
GEMFIBROZIL gemfibrozil TABLET;ORAL 075034 ANDA Aidarex Pharmaceuticals LLC 33261-146 N 33261-146-90

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jul 20, 1998TE:ABRLD:No

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