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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 021454

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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 are sixty-nine drug master file entries for this compound. Nineteen 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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