FDA.reportPublic FDA data

Application 020489

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANDRODERMTESTOSTERONEFILM, EXTENDED RELEASE;TRANSDERMAL2.5MG/24HRNoNo
002ANDRODERMTESTOSTERONEFILM, EXTENDED RELEASE;TRANSDERMAL5MG/24HRNoNo
003ANDRODERMTESTOSTERONEFILM, EXTENDED RELEASE;TRANSDERMAL2MG/24HRYesYes
004ANDRODERMTESTOSTERONEFILM, EXTENDED RELEASE;TRANSDERMAL4MG/24HRYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-5990AndrodermTestosteroneAllergan, Inc.NDACurrent
0023-5990AndrodermTestosteroneAllergan, Inc.NDACurrent
0023-5990AndrodermTestosteroneAllergan, Inc.NDACurrent
0023-5992AndrodermTestosteroneAllergan, Inc.NDACurrent
0023-5992AndrodermTestosteroneAllergan, Inc.NDACurrent
0023-5992AndrodermTestosteroneAllergan, Inc.NDACurrent
52544-076AndrodermTestosteroneActavis Pharma, Inc.NDACurrent
52544-077AndrodermTestosteroneActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62941SUPPL2020-05-13
62916SUPPL2020-05-12
60057SUPPL2019-09-20
60053SUPPL2019-09-19
45752SUPPL2016-11-01
45671SUPPL2016-10-27
25041SUPPL2015-05-13
12632SUPPL2015-05-13
34706SUPPL2014-06-23
2596SUPPL2014-06-23
25040SUPPL2012-05-02
34705SUPPL2012-05-01
25039SUPPL2011-10-25
12631SUPPL2011-10-25
20679SUPPL2007-07-06
34704SUPPL2006-05-22
2595SUPPL2006-05-22
25038SUPPL2002-08-09
25037SUPPL2002-01-15
41394SUPPL1997-05-02