Last Updated: November 8, 2026

Details for New Drug Application (NDA): 080475

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NDA 080475 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 080475

Tradename:	METHYLTESTOSTERONE
Applicant:	Purepac Pharm
Ingredient:	methyltestosterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 080475

Anabolic Agents
Antineoplastic Agents, Hormonal

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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