Last Updated: November 8, 2026

Details for New Drug Application (NDA): 213922

« Back to Dashboard

NDA 213922 describes TESTOSTERONE, which is a drug marketed by Actavis Labs Ut Inc, Alembic, Amneal, Encube, Lupin, Padagis Israel, Perrigo Israel, Twi Pharms, Xiromed, Ani Pharms, Strides Pharma Intl, Dr Reddys, Watson Labs, Apotex, Cipla, Am Regent, Bpi Labs, Caplin One Labs, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sun Pharm Inds Ltd, Watson Pharms Inc, Wilshire Pharms Inc, Nexus, Bel Mar, Elkins Sinn, and Lilly, and is included in sixty NDAs. It is available from twelve suppliers. Additional details are available on the TESTOSTERONE profile page.

The generic ingredient in TESTOSTERONE is testosterone propionate. There are six drug master file entries for this compound. Additional details are available on the testosterone propionate profile page.

Summary for 213922

Tradename:	TESTOSTERONE
Applicant:	Alembic
Ingredient:	testosterone
Patents:	0

Pharmacology for NDA: 213922

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 213922

Androgens

Suppliers and Packaging for NDA: 213922

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE	testosterone	GEL, METERED;TRANSDERMAL	213922	ANDA	Alembic Pharmaceuticals Inc.	62332-552	62332-552-88	1 BOTTLE, PUMP in 1 CARTON (62332-552-88) / 88 g in 1 BOTTLE, PUMP

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL, METERED;TRANSDERMAL			Strength	1.62% (20.25MG/1.25GM ACTUATION)
Approval Date:	Mar 3, 2021	TE:		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.