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Last Updated: April 23, 2024

Details for New Drug Application (NDA): 021015

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NDA 021015 describes ANDROGEL, which is a drug marketed by Besins Hlthcare and is included in two NDAs. It is available from two suppliers. There are eight patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ANDROGEL profile page.

The generic ingredient in ANDROGEL is testosterone. There are sixty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the testosterone profile page.

Summary for 021015

Tradename:	ANDROGEL
Applicant:	Besins Hlthcare
Ingredient:	testosterone
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 021015

Androgens

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TRANSDERMAL			Strength	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 28, 2000	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL;TRANSDERMAL			Strength	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 28, 2000	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	GEL, METERED;TRANSDERMAL			Strength	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 26, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021015

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-002	Feb 28, 2000	⤷ Try a Trial	⤷ Try a Trial
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-002	Feb 28, 2000	⤷ Try a Trial	⤷ Try a Trial
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	021015-003	Sep 26, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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