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Last Updated: November 14, 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. 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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TRANSDERMALStrength25MG/2.5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 28, 2000TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 28, 2000TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:GEL, METERED;TRANSDERMALStrength12.5MG/1.25GM ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Sep 26, 2003TE:RLD:Yes

Expired US Patents for NDA 021015

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

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