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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 075298


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NDA 075298 describes FLUTAMIDE, which is a drug marketed by Actavis Labs Fl Inc, Chartwell Rx, Cipla, Mylan, 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 075298
Tradename:FLUTAMIDE
Applicant:Waylis Therap
Ingredient:flutamide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075298
Mechanism of ActionAndrogen Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 075298
Suppliers and Packaging for NDA: 075298
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUTAMIDE flutamide CAPSULE;ORAL 075298 ANDA Waylis Therapeutics LLC 80725-600 80725-600-18 1 BOTTLE, PLASTIC in 1 BOX (80725-600-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

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

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