Last Updated: September 24, 2026

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, Chartwell Rx, Cipla, Pharmobedient, and Waylis Therap, and is included in five NDAs. It is available from one supplier. Additional details are available on the FLUTAMIDE profile page.

The generic ingredient in FLUTAMIDE is flutamide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the flutamide profile page.

Summary for 075820

Tradename:	FLUTAMIDE
Applicant:	Actavis Labs Fl Inc
Ingredient:	flutamide
Patents:	0

Medical Subject Heading (MeSH) Categories for 075820

Androgen Antagonists
Antineoplastic Agents, Hormonal

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	125MG
Approval Date:	Sep 18, 2001	TE:		RLD:	No

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