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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 080313

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NDA 080313 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 are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the methyltestosterone profile page.

Summary for 080313

Tradename:	METHYLTESTOSTERONE
Applicant:	Tablicaps
Ingredient:	methyltestosterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 080313

Anabolic Agents
Antineoplastic Agents, Hormonal

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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