Details for New Drug Application (NDA): 077836
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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 077836
Tradename: | GEMFIBROZIL |
Applicant: | Invagen Pharms |
Ingredient: | gemfibrozil |
Patents: | 0 |
Pharmacology for NDA: 077836
Mechanism of Action | Peroxisome Proliferator-activated Receptor alpha Agonists |
Medical Subject Heading (MeSH) Categories for 077836
Suppliers and Packaging for NDA: 077836
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 077836 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-745 | 43063-745-60 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-745-60) |
GEMFIBROZIL | gemfibrozil | TABLET;ORAL | 077836 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-745 | 43063-745-93 | 180 TABLET in 1 BOTTLE, PLASTIC (43063-745-93) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 600MG | ||||
Approval Date: | Jul 27, 2006 | TE: | AB | RLD: | No |
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