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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 215270

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NDA 215270 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 215270

Tradename:	METHYLTESTOSTERONE
Applicant:	Novitium Pharma
Ingredient:	methyltestosterone
Patents:	0

Pharmacology for NDA: 215270

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 215270

Anabolic Agents
Antineoplastic Agents, Hormonal

Suppliers and Packaging for NDA: 215270

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLTESTOSTERONE	methyltestosterone	CAPSULE;ORAL	215270	ANDA	ANI Pharmaceuticals, Inc.	70954-255	70954-255-10	100 CAPSULE in 1 BOTTLE (70954-255-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Feb 18, 2022	TE:	AB	RLD:	No

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