Details for New Drug Application (NDA): 207631
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NDA 207631 describes NILUTAMIDE, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the NILUTAMIDE profile page.
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.
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 |
| Formulation / Manufacturing: | see details |
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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