Details for New Drug Application (NDA): 202726
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NDA 202726 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 202726
| Tradename: | GEMFIBROZIL |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | gemfibrozil |
| Patents: | 0 |
Pharmacology for NDA: 202726
| Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
Medical Subject Heading (MeSH) Categories for 202726
Suppliers and Packaging for NDA: 202726
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 202726 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8354 | 0615-8354-39 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8354-39) |
| GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 202726 | ANDA | Rising Pharma Holdings, Inc. | 16571-784 | 16571-784-06 | 60 TABLET, FILM COATED in 1 BOTTLE (16571-784-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
| Approval Date: | Sep 16, 2015 | TE: | AB | RLD: | No | ||||
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