Details for New Drug Application (NDA): 204189
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NDA 204189 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 204189
| Tradename: | GEMFIBROZIL |
| Applicant: | Cadila |
| Ingredient: | gemfibrozil |
| Patents: | 0 |
Pharmacology for NDA: 204189
| Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
Medical Subject Heading (MeSH) Categories for 204189
Suppliers and Packaging for NDA: 204189
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 204189 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-553 | 68382-553-01 | 100 TABLET in 1 BOTTLE (68382-553-01) |
| GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 204189 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 68382-553 | 68382-553-05 | 500 TABLET in 1 BOTTLE (68382-553-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Aug 28, 2018 | TE: | RLD: | No | |||||
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