FDA.reportPublic FDA data

Application 204399

Type
NDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002VOGELXOTESTOSTERONEGEL;TRANSDERMAL50MG/5GM PACKETNoNo
003VOGELXOTESTOSTERONEGEL, METERED;TRANSDERMAL12.5MG/1.25GM ACTUATIONNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0245-0871VogelxoTestosteroneUpsher-Smith Laboratories, LLCNDACurrent
0245-0871VogelxoTestosteroneUpsher-Smith Laboratories, LLCNDACurrent
0245-0871VogelxoTestosteroneUpsher-Smith Laboratories, LLCNDACurrent
0245-0871VogelxoTestosteroneUpsher-Smith Laboratories, LLCNDACurrent
0245-0872VogelxoTestosteroneUpsher-Smith Laboratories, LLCNDACurrent
0245-0872VogelxoTestosteroneUpsher-Smith Laboratories, LLCNDACurrent
0245-0872VogelxoTestosteroneUpsher-Smith Laboratories, LLCNDACurrent
0245-0872VogelxoTestosteroneUpsher-Smith Laboratories, LLCNDACurrent
0832-1120TestosteroneTestosteroneUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1120TestosteroneTestosteroneUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1120TestosteroneTestosteroneUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1121TestosteroneTestosteroneUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1121TestosteroneTestosteroneUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent
0832-1121TestosteroneTestosteroneUpsher-Smith Laboratories, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82862SUPPL 2025-07-15
82853SUPPL 2025-07-14
82852SUPPL 2025-07-14
62803SUPPL2020-05-01
62802SUPPL2020-05-01
62792SUPPL2020-05-01
58916SUPPL2019-06-03
58733SUPPL2019-05-15
58732SUPPL2019-05-15
58672SUPPL2019-05-14
45743SUPPL2016-11-01
45681SUPPL2016-10-27
40384SUPPL2015-05-13
10338SUPPL2015-05-13
44900ORIG2015-04-22
22956ORIG2015-04-22
24122ORIG2014-06-26
40383ORIG2014-06-10
10337ORIG2014-06-05
10336ORIG2013-08-21