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Details for New Drug Application (NDA): 075034

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NDA 075034 describes GEMFIBROZIL, which is a drug marketed by Impax Pharms, Blu Caribe, Sandoz, Aurobindo Pharma Ltd, Purepac Pharm, Apotex, Invagen Pharms, Sun Pharm Inds Inc, Watson Labs, Mylan, Teva, Cadila Pharms Ltd, Dava Pharms Inc, 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. Fifty-one suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.

Summary for NDA: 075034

Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 075034

Suppliers and Packaging for NDA: 075034

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 075034 ANDA Major Pharmaceuticals 0904-5379 0904-5379-40 500 TABLET, FILM COATED in 1 BOTTLE (0904-5379-40)
TABLET;ORAL 075034 ANDA Major Pharmaceuticals 0904-5379 0904-5379-52 60 TABLET, FILM COATED in 1 BOTTLE (0904-5379-52)

Summary for product number 001

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

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