Details for New Drug Application (NDA): 203266
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NDA 203266 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 203266
| Tradename: | GEMFIBROZIL |
| Applicant: | Cadila Pharms Ltd |
| Ingredient: | gemfibrozil |
| Patents: | 0 |
Pharmacology for NDA: 203266
| Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
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 | Cadila Pharmaceuticals Limited | 71209-008 | 71209-008-03 | 60 TABLET in 1 BOTTLE (71209-008-03) |
| GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 203266 | ANDA | Cadila Pharmaceuticals Limited | 71209-008 | 71209-008-08 | 180 TABLET in 1 BOTTLE (71209-008-08) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Jun 17, 2016 | TE: | AB | RLD: | No | ||||
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