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Details for New Drug Application (NDA): 075820

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NDA 075820 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: 075820

Tradename:
FLUTAMIDE
Applicant:
Actavis Labs Fl Inc
Ingredient:
flutamide
Patents:0
Therapeutic Class:Hormonal Agents, Suppressant (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for NDA: 075820

Mechanism of ActionAndrogen Receptor Antagonists

Suppliers and Packaging for NDA: 075820

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUTAMIDE
flutamide
CAPSULE;ORAL 075820 ANDA Actavis Pharma, Inc. 0591-2466 0591-2466-18 180 CAPSULE in 1 BOTTLE, PLASTIC (0591-2466-18)

Summary for product number 001

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


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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 verifification 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.

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