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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Fish and Richardson
Covington
McKesson
Boehringer Ingelheim
McKinsey
AstraZeneca
Dow
Argus Health

Generated: April 21, 2018

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. Two 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
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
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 N 62559-173-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 15, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Covington
Deloitte
US Army
QuintilesIMS
Colorcon
Daiichi Sankyo
Baxter
Teva

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