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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 022309


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NDA 022309 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. Twenty-one suppliers are listed for this compound. Additional details are available on the testosterone profile page.
Summary for 022309
Tradename:ANDROGEL
Applicant:Besins Hlthcare
Ingredient:testosterone
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 022309
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 0051-8462-33 1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) / 88 g in 1 BOTTLE, PUMP
ANDROGEL testosterone GEL;TRANSDERMAL 022309 NDA AbbVie Inc. 0051-8462 0051-8462-33 1 BOTTLE, PUMP in 1 CARTON (0051-8462-33) / 88 g in 1 BOTTLE, PUMP

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:⤷  Try a TrialPatent Expiration:Oct 12, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent 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
Patent:⤷  Try a TrialPatent 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

Expired US Patents for NDA 022309

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-003 Sep 7, 2012 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL;TRANSDERMAL 022309-002 Sep 7, 2012 ⤷  Try a Trial ⤷  Try a Trial
Besins Hlthcare ANDROGEL testosterone GEL, METERED;TRANSDERMAL 022309-001 Apr 29, 2011 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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