You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 28, 2024

Details for New Drug Application (NDA): 075780

✉ Email this page to a colleague

« Back to Dashboard

NDA 075780 describes FLUTAMIDE, which is a drug marketed by Actavis Labs Fl Inc, Chartwell Rx, Cipla, Norvium Bioscience, and Waylis Therap, and is included in five NDAs. It is available from two 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. Two suppliers are listed for this compound. Additional details are available on the flutamide profile page.

Summary for 075780

Tradename:	FLUTAMIDE
Applicant:	Cipla
Ingredient:	flutamide
Patents:	0

Pharmacology for NDA: 075780

Mechanism of Action	Androgen Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 075780

Androgen Antagonists
Antineoplastic Agents, Hormonal

Suppliers and Packaging for NDA: 075780

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUTAMIDE	flutamide	CAPSULE;ORAL	075780	ANDA	Cipla USA Inc.	69097-915	69097-915-12	500 CAPSULE in 1 BOTTLE (69097-915-12)
FLUTAMIDE	flutamide	CAPSULE;ORAL	075780	ANDA	Cipla USA Inc.	69097-915	69097-915-91	180 CAPSULE in 1 BOTTLE (69097-915-91)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	125MG
Approval Date:	Sep 19, 2001	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.