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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cipla
Chubb
McKesson
US Department of Justice
Harvard Business School
Baxter
Queensland Health
Johnson and Johnson

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088342

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NDA 088342 describes FLUOXYMESTERONE, which is a drug marketed by Usl Pharma, Valeant Pharm Intl, and Watson Labs, and is included in five NDAs. It is available from one supplier. Additional details are available on the FLUOXYMESTERONE profile page.

The generic ingredient in FLUOXYMESTERONE is fluoxymesterone. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fluoxymesterone profile page.
Summary for 088342
Tradename:FLUOXYMESTERONE
Applicant:Usl Pharma
Ingredient:fluoxymesterone
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 088342
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 088342
Suppliers and Packaging for NDA: 088342
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOXYMESTERONE fluoxymesterone TABLET;ORAL 088342 ANDA Upsher-Smith Laboratories, LLC 0832-0086 N 0832-0086-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 21, 1983TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Cantor Fitzgerald
Federal Trade Commission
Fish and Richardson
Baxter
Queensland Health
Cipla
Daiichi Sankyo
Deloitte

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