Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021454

✉ Email this page to a colleague

NDA 021454 describes TESTIM, which is a drug marketed by Endo Operations and is included in one NDA. It is available from one supplier. Additional details are available on the TESTIM profile page.

The generic ingredient in TESTIM is testosterone. There is one drug master file entry for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the testosterone profile page.

Summary for 021454

Tradename:	TESTIM
Applicant:	Endo Operations
Ingredient:	testosterone
Patents:	0

Pharmacology for NDA: 021454

Mechanism of Action	Androgen Receptor Agonists

Medical Subject Heading (MeSH) Categories for 021454

Androgens

Suppliers and Packaging for NDA: 021454

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTIM	testosterone	GEL;TRANSDERMAL	021454	NDA	Endo USA, Inc.	66887-001	66887-001-05	30 TUBE in 1 CARTON (66887-001-05) / 5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;TRANSDERMAL			Strength	50MG/5GM PACKET
Approval Date:	Oct 31, 2002	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 021454

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Start Trial	⤷ Start Trial
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Start Trial	⤷ Start Trial
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Start Trial	⤷ Start Trial
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Start Trial	⤷ Start Trial
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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.