Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021463

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NDA 021463 describes FORTESTA, which is a drug marketed by Endo Operations and is included in one NDA. Additional details are available on the FORTESTA profile page.

The generic ingredient in FORTESTA 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 021463

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

Medical Subject Heading (MeSH) Categories for 021463

Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL, METERED;TRANSDERMAL			Strength	10MG/0.5GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 29, 2010	TE:		RLD:	Yes

Expired US Patents for NDA 021463

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	FORTESTA	testosterone	GEL, METERED;TRANSDERMAL	021463-001	Dec 29, 2010	6,319,913	⤷ Start Trial
Endo Operations	FORTESTA	testosterone	GEL, METERED;TRANSDERMAL	021463-001	Dec 29, 2010	6,579,865	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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