Details for New Drug Application (NDA): 078012
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NDA 078012 describes GEMFIBROZIL, which is a drug marketed by Natco, Purepac Pharm, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Chartwell Rx, Epic Pharma Llc, 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.
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: | Epic Pharma Llc |
| 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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