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Serving 500+ biopharmaceutical companies globally:

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Generated: July 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075298

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NDA 075298 describes FLUTAMIDE, which is a drug marketed by Sandoz, Actavis Labs Fl Inc, Mylan, Cipla Ltd, and Par Pharm, 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 NDA: 075298

Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 075298

Mechanism of ActionAndrogen Receptor Antagonists

Suppliers and Packaging for NDA: 075298

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 075298 ANDA Par Pharmaceutical Inc. 49884-753 49884-753-05 500 CAPSULE in 1 BOTTLE (49884-753-05)
CAPSULE;ORAL 075298 ANDA Par Pharmaceutical Inc. 49884-753 49884-753-13 180 CAPSULE in 1 BOTTLE (49884-753-13)

Summary for product number 001

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

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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Express Scripts
Federal Trade Commission
Fish and Richardson

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