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Generated: September 21, 2018

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Details for New Drug Application (NDA): 022309

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NDA 022309 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-five 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 022309
Tradename:ANDROGEL
Applicant:Abbvie
Ingredient:testosterone
Patents:11
Formulation / Manufacturing:see details
Pharmacology for NDA: 022309
Ingredient-typeAndrostanes
Mechanism of ActionAndrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for 022309
Suppliers and Packaging for NDA: 022309
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309 NDA AbbVie Inc. 0051-8462 0051-8462-30 30 PACKET in 1 CARTON (0051-8462-30) > 2.5 g in 1 PACKET (0051-8462-01)
ANDROGEL testosterone GEL;TRANSDERMAL 022309 NDA AbbVie Inc. 0051-8462 0051-8462-30 30 PACKET in 1 CARTON (0051-8462-30) > 2.5 g in 1 PACKET (0051-8462-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL, METERED;TRANSDERMALStrength1.62% (20.25MG/1.25GM ACTUATION)
Approval Date:Apr 29, 2011TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Mar 2, 2021Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Oct 12, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 12, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

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AstraZeneca
QuintilesIMS
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