You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 16, 2025

Details for New Drug Application (NDA): 204851

✉ Email this page to a colleague

« Back to Dashboard

NDA 204851 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 204851

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

Pharmacology for NDA: 204851

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 204851

Anabolic Agents
Antineoplastic Agents, Hormonal

Suppliers and Packaging for NDA: 204851

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METHYLTESTOSTERONE	methyltestosterone	CAPSULE;ORAL	204851	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1408	0115-1408-01	100 CAPSULE in 1 BOTTLE (0115-1408-01)
METHYLTESTOSTERONE	methyltestosterone	CAPSULE;ORAL	204851	ANDA	Amneal Pharmaceuticals of New York LLC	0115-1408	0115-1408-03	1000 CAPSULE in 1 BOTTLE (0115-1408-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Sep 21, 2015	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.