Details for New Drug Application (NDA): 207631
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The generic ingredient in NILUTAMIDE is nilutamide. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nilutamide profile page.
Summary for 207631
Tradename: | NILUTAMIDE |
Applicant: | Ani Pharms |
Ingredient: | nilutamide |
Patents: | 0 |
Pharmacology for NDA: 207631
Mechanism of Action | Androgen Receptor Antagonists |
Suppliers and Packaging for NDA: 207631
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NILUTAMIDE | nilutamide | TABLET;ORAL | 207631 | ANDA | ANI Pharmaceuticals, Inc. | 62559-173 | 62559-173-31 | 3 BLISTER PACK in 1 CARTON (62559-173-31) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jul 15, 2016 | TE: | AB | RLD: | No |
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