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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207631

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NDA 207631 describes NILUTAMIDE, which is a drug marketed by Ani Pharms Inc 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.
Summary for 207631
Tradename:NILUTAMIDE
Applicant:Ani Pharms Inc
Ingredient:nilutamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207631
Mechanism of ActionAndrogen 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:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 15, 2016TE:ABRLD:No

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