Details for New Drug Application (NDA): 078012
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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 078012
Tradename: | GEMFIBROZIL |
Applicant: | Caribe Holdings |
Ingredient: | gemfibrozil |
Patents: | 0 |
Pharmacology for NDA: 078012
Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
Medical Subject Heading (MeSH) Categories for 078012
Suppliers and Packaging for NDA: 078012
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 078012 | ANDA | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-260 | 24658-260-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-05) |
GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 078012 | ANDA | PuraCap Laboratories LLC dba Blu Pharmaceuticals | 24658-260 | 24658-260-18 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (24658-260-18) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Mar 26, 2007 | TE: | AB | RLD: | No |
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