Last Updated: September 24, 2026

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 one supplier. 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 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 021015
Tradename:ANDROGEL
Applicant:Besins Hlthcare
Ingredient:testosterone
Patents:0
Medical Subject Heading (MeSH) Categories for 021015
Androgens
Suppliers and Packaging for NDA: 021015
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANDROGEL testosterone GEL, METERED;TRANSDERMAL 021015 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-953 66993-953-44 2 BOTTLE, PUMP in 1 CARTON (66993-953-44) / 88 g in 1 BOTTLE, PUMP (66993-953-88)
ANDROGEL testosterone GEL, METERED;TRANSDERMAL 021015 NDA AUTHORIZED GENERIC Prasco Laboratories 66993-954 66993-954-30 30 PACKET in 1 CARTON (66993-954-30) / 2.5 g in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage: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PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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:AB1RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 28, 2000TE:AB1RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage: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ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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:AB1RLD:Yes

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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