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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077836

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NDA 077836 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 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-one suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.
Summary for 077836
Applicant:Invagen Pharms
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077836
Medical Subject Heading (MeSH) Categories for 077836
Suppliers and Packaging for NDA: 077836
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMFIBROZIL gemfibrozil TABLET;ORAL 077836 ANDA West-ward Pharmaceutical Corp 0143-9130 E 0143-9130-60
GEMFIBROZIL gemfibrozil TABLET;ORAL 077836 ANDA West-ward Pharmaceutical Corp 0143-9130 E 0143-9130-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jul 27, 2006TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim

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