FDA.reportPublic FDA data

Application 022309

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANDROGELTESTOSTERONEGEL, METERED;TRANSDERMAL1.62% (20.25MG/1.25GM ACTUATION)YesYes
002ANDROGELTESTOSTERONEGEL;TRANSDERMAL1.62% (20.25MG/1.25GM PACKET)YesNo
003ANDROGELTESTOSTERONEGEL;TRANSDERMAL1.62% (40.5MG/2.5GM PACKET)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0051-8462AndrogelTestosteroneAbbVie Inc.NDACurrent
0051-8462AndrogelTestosteroneAbbVie Inc.NDACurrent
0051-8462AndrogelTestosteroneAbbVie Inc.NDACurrent
0051-8462AndrogelTestosteroneAbbVie Inc.NDACurrent
0051-8462AndrogelTestosteroneAbbVie Inc.NDACurrent
50090-1306AndrogelTestosteroneA-S Medication Solutions LLCNDACurrent
68382-362TestosteroneTestosteroneZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-362TestosteroneTestosteroneZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-362TestosteroneTestosteroneZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-362TestosteroneTestosteroneZydus Pharmaceuticals USA IncNDACurrent
68382-362TestosteroneTestosteroneZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82872SUPPL 2025-07-15
82837SUPPL 2025-07-14
82836SUPPL 2025-07-14
58915SUPPL2019-06-03
58754SUPPL2019-05-16
58752SUPPL2019-05-16
58657SUPPL2019-05-13
57926SUPPL2019-03-07
57831SUPPL2019-02-28
45770APPL2016-11-02
45741SUPPL2016-11-01
45677SUPPL2016-10-27
38551SUPPL2015-05-13
29571SUPPL2015-05-13
17223SUPPL2014-11-20
7213SUPPL2014-11-18
38550SUPPL2014-06-23
7214SUPPL2014-06-23
21990SUPPL2014-01-16
29570SUPPL2013-05-22
17222SUPPL2013-05-20
29569SUPPL2013-03-15
38549SUPPL2012-09-11
29568SUPPL2012-09-10
44735ORIG2011-11-17
21989ORIG2011-11-17
7212ORIG2011-05-05
38548ORIG2011-04-29