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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
US Army
Federal Trade Commission

Generated: January 23, 2018

DrugPatentWatch Database Preview

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, Cipla Ltd, Mylan, Par Pharm, and Sandoz, and is included in five NDAs. It is available from five 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. Five suppliers are listed for this compound. Additional details are available on the flutamide profile page.
Summary for 075298
Applicant:Par Pharm
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
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 Par Pharmaceutical, Inc. 49884-753 49884-753-13 180 CAPSULE in 1 BOTTLE (49884-753-13)
FLUTAMIDE flutamide CAPSULE;ORAL 075298 ANDA Golden State Medical Supply, Inc. 60429-272 60429-272-18 180 CAPSULE in 1 BOTTLE (60429-272-18)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Fish and Richardson
Johnson and Johnson

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