Details for New Drug Application (NDA): 021015

✉ Email this page to a colleague

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. Nineteen 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

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GEL;TRANSDERMAL			Strength	25MG/2.5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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Dosage:	GEL;TRANSDERMAL			Strength	50MG/5GM PACKET Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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		Strength	12.5MG/1.25GM ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Besins Hlthcare	ANDROGEL	testosterone	GEL, METERED;TRANSDERMAL	021015-003	Sep 26, 2003	⤷ Sign Up	⤷ Sign Up
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-001	Feb 28, 2000	⤷ Sign Up	⤷ Sign Up
Besins Hlthcare	ANDROGEL	testosterone	GEL;TRANSDERMAL	021015-001	Feb 28, 2000	⤷ Sign Up	⤷ Sign Up
>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. 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.