Last Updated: November 9, 2026

Details for New Drug Application (NDA): 080973

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NDA 080973 describes METHYLTESTOSTERONE, which is a drug marketed by Heather, Impax Labs Inc, Novitium Pharma, Impax Labs, Lilly, Purepac Pharm, Pvt Form, Tablicaps, Usl Pharma, Inwood Labs, Kv Pharm, Lannett, Parke Davis, Watson Labs, and West Ward, and is included in twenty-eight NDAs. It is available from two suppliers. Additional details are available on the METHYLTESTOSTERONE profile page.

The generic ingredient in METHYLTESTOSTERONE is methyltestosterone. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the methyltestosterone profile page.

Summary for 080973

Tradename:	METHYLTESTOSTERONE
Applicant:	Inwood Labs
Ingredient:	methyltestosterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 080973

Anabolic Agents
Antineoplastic Agents, Hormonal

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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