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Last Updated: May 26, 2022

Details for New Drug Application (NDA): 021015


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NDA 021015 describes ANDROGEL, which is a drug marketed by Abbvie 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:Abbvie
Ingredient:testosterone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021015
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 021015
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 AbbVie Inc. 0051-8425 0051-8425-30 30 PACKET in 1 CARTON (0051-8425-30) > 2.5 g in 1 PACKET (0051-8425-01)
ANDROGEL testosterone GEL;TRANSDERMAL 021015 NDA AbbVie Inc. 0051-8425 0051-8425-30 30 PACKET in 1 CARTON (0051-8425-30) > 2.5 g in 1 PACKET (0051-8425-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TRANSDERMALStrength25MG/2.5GM PACKET
Approval Date:Feb 28, 2000TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:GEL;TRANSDERMALStrength50MG/5GM PACKET
Approval Date:Feb 28, 2000TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:GEL, METERED;TRANSDERMALStrength12.5MG/1.25GM ACTUATION
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
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-002 Feb 28, 2000 See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 021015-003 Sep 26, 2003 See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL, METERED;TRANSDERMAL 021015-003 Sep 26, 2003 See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-001 Feb 28, 2000 See Plans and Pricing See Plans and Pricing
Abbvie ANDROGEL testosterone GEL;TRANSDERMAL 021015-001 Feb 28, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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