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Generated: October 16, 2018

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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 eleven 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-seven drug master file entries for this compound. Seventeen 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:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 021015
Ingredient-typeAndrostanes
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:RXDosage:GEL;TRANSDERMALStrength25MG/2.5GM PACKET
Approval Date:Feb 28, 2000TE:AB1RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Mar 1, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Mar 2, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Mar 2, 2021Product Flag?Substance Flag?Delist Request?Y

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