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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203266


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NDA 203266 describes GEMFIBROZIL, which is a drug marketed by Mylan, 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, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in twenty NDAs. It is available from thirty-two suppliers. Additional details are available on the GEMFIBROZIL profile page.

The generic ingredient in GEMFIBROZIL is gemfibrozil. Thirty-three suppliers are listed for this compound. Additional details are available on the gemfibrozil profile page.
Summary for 203266
Tradename:GEMFIBROZIL
Applicant:Cadila Pharms Ltd
Ingredient:gemfibrozil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203266
Medical Subject Heading (MeSH) Categories for 203266
Suppliers and Packaging for NDA: 203266
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMFIBROZIL gemfibrozil TABLET;ORAL 203266 ANDA NuCare Pharmaceuticals,Inc. 68071-2296 68071-2296-3 30 TABLET in 1 BOTTLE (68071-2296-3)
GEMFIBROZIL gemfibrozil TABLET;ORAL 203266 ANDA Cadila Pharmaceuticals Limited 71209-008 71209-008-03 60 TABLET in 1 BOTTLE (71209-008-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jun 17, 2016TE:ABRLD:No

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