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Generated: May 24, 2017

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Details for New Drug Application (NDA): 077836

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NDA 077836 describes GEMFIBROZIL, which is a drug marketed by Impax Pharms, Caribe Holdings, Sandoz, Aurobindo Pharma Ltd, Purepac Pharm, Apotex, Invagen Pharms, Sun Pharm Inds Inc, Watson Labs, Mylan, Teva, Cadila Pharms Ltd, Chartwell Molecules, Northstar Hlthcare, and Hikma Pharms, 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 NDA: 077836

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077836

Suppliers and Packaging for NDA: 077836

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 077836 ANDA West-ward Pharmaceutical Corp 0143-9130 0143-9130-05 500 TABLET, FILM COATED in 1 BOTTLE (0143-9130-05)
TABLET;ORAL 077836 ANDA West-ward Pharmaceutical Corp 0143-9130 0143-9130-60 60 TABLET, FILM COATED in 1 BOTTLE (0143-9130-60)

Summary for product number 001

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

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