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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Fish and Richardson

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075820

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NDA 075820 describes FLUTAMIDE, which is a drug marketed by Actavis Labs Fl Inc, Cipla Ltd, Mylan, Par Pharm, and Yaopharma Co Ltd, and is included in five NDAs. It is available from four suppliers. Additional details are available on the FLUTAMIDE profile page.

The generic ingredient in FLUTAMIDE is flutamide. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the flutamide profile page.
Summary for 075820
Applicant:Actavis Labs Fl Inc
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 075820
Mechanism of ActionAndrogen Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 075820
Suppliers and Packaging for NDA: 075820
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUTAMIDE flutamide CAPSULE;ORAL 075820 ANDA Actavis Pharma, Inc. 0591-2466 N 0591-2466-18

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength125MG
Approval Date:Sep 18, 2001TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
US Department of Justice
Daiichi Sankyo

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