Details for New Drug Application (NDA): 214603
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NDA 214603 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.
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 214603
| Tradename: | GEMFIBROZIL |
| Applicant: | Ascent Pharms Inc |
| Ingredient: | gemfibrozil |
| Patents: | 0 |
Pharmacology for NDA: 214603
| Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
Medical Subject Heading (MeSH) Categories for 214603
Suppliers and Packaging for NDA: 214603
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 214603 | ANDA | Camber Pharmaceuticals, Inc. | 31722-128 | 31722-128-05 | 500 TABLET in 1 BOTTLE (31722-128-05) |
| GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 214603 | ANDA | Camber Pharmaceuticals, Inc. | 31722-128 | 31722-128-60 | 60 TABLET in 1 BOTTLE (31722-128-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Jan 13, 2021 | TE: | AB | RLD: | No | ||||
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