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 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 021463

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

Pharmacology for NDA: 021463

Mechanism of Action	Androgen Receptor Agonists

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
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	⤷ Sign Up	⤷ Sign Up
Endo Operations	FORTESTA	testosterone	GEL, METERED;TRANSDERMAL	021463-001	Dec 29, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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