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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 077836


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NDA 077836 describes GEMFIBROZIL, which is a drug marketed by Natco, Purepac Pharm, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Caribe Holdings, Chartwell Molecules, Chartwell Rx, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Norvium Bioscience, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in twenty NDAs. It is available from thirty-three suppliers. Additional details are available on the GEMFIBROZIL profile page.

The generic ingredient in GEMFIBROZIL is gemfibrozil. Thirty-four suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.
Summary for 077836
Tradename:GEMFIBROZIL
Applicant:Invagen Pharms
Ingredient:gemfibrozil
Patents:0
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 PD-Rx Pharmaceuticals, Inc. 43063-745 43063-745-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-745-60)
GEMFIBROZIL gemfibrozil TABLET;ORAL 077836 ANDA PD-Rx Pharmaceuticals, Inc. 43063-745 43063-745-93 180 TABLET in 1 BOTTLE, PLASTIC (43063-745-93)

Profile for product number 001

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

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