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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 088221

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NDA 088221 describes FLUOXYMESTERONE, which is a drug marketed by Upsher Smith Labs, Valeant Pharm Intl, and Watson Labs, and is included in five NDAs. 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. Additional details are available on the fluoxymesterone profile page.

Summary for 088221

Tradename:	FLUOXYMESTERONE
Applicant:	Valeant Pharm Intl
Ingredient:	fluoxymesterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 088221

Anabolic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 5, 1983	TE:		RLD:	No

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