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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 080767

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NDA 080767 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 080767

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

Pharmacology for NDA: 080767

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 080767

Anabolic Agents
Antineoplastic Agents, Hormonal

Suppliers and Packaging for NDA: 080767

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLTESTOSTERONE	methyltestosterone	TABLET;ORAL	080767	ANDA	Amneal Pharmaceuticals of New York LLC	0115-7037	0115-7037-01	100 TABLET in 1 BOTTLE (0115-7037-01)

Profile for product number 002

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

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