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Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Chinese Patent Office
Cantor Fitzgerald

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075780

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NDA 075780 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 075780
Applicant:Cipla Ltd
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 075780
Mechanism of ActionAndrogen Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 075780
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 Teva Pharmaceuticals USA, Inc. 0172-4960 0172-4960-70 500 CAPSULE in 1 BOTTLE (0172-4960-70)
FLUTAMIDE flutamide CAPSULE;ORAL 075780 ANDA Teva Pharmaceuticals USA, Inc. 0172-4960 0172-4960-58 180 CAPSULE in 1 BOTTLE (0172-4960-58)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength125MG
Approval Date:Sep 19, 2001TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Daiichi Sankyo

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