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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 078033

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NDA 078033 describes OXANDROLONE, which is a drug marketed by Par Pharm, Roxane, Sandoz, and Upsher Smith Labs, and is included in five NDAs. Additional details are available on the OXANDROLONE profile page.

The generic ingredient in OXANDROLONE is oxandrolone. There are ten drug master file entries for this compound. Additional details are available on the oxandrolone profile page.

Summary for 078033

Tradename:	OXANDROLONE
Applicant:	Upsher Smith Labs
Ingredient:	oxandrolone
Patents:	0

Medical Subject Heading (MeSH) Categories for 078033

Anabolic Agents
Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 22, 2007	TE:		RLD:	No

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