FDA.reportPublic FDA data

Application 205781

Type
ANDA
Sponsor
PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONETESTOSTERONEGEL;TRANSDERMAL1.62% (20.25MG/1.25GM PACKET)NoNo
002TESTOSTERONETESTOSTERONEGEL;TRANSDERMAL1.62% (40.5MG/2.5GM PACKET)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-967testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-967testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-968testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-968testosteronetestosteroneNorthstar Rx LLCANDACurrent
16714-968testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-968testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-968testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-968testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-969testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-969testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-969testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-969testosteronetestosteroneNorthstar RxLLCANDACurrent
16714-969testosteronetestosteroneNorthstar Rx LLCANDACurrent
16714-969testosteronetestosteroneNorthstar RxLLCANDACurrent
45802-281testosteronetestosteronePerrigo New York IncANDACurrent
45802-281testosteronetestosteronePadagis Israel Pharmaceuticals LtdANDACurrent
45802-281testosteronetestosteronePerrigo New York IncANDACurrent
45802-281testosteronetestosteronePerrigo New York IncANDACurrent
45802-366testosteronetestosteronePerrigo New York IncANDACurrent
45802-366testosteronetestosteronePadagis Israel Pharmaceuticals LtdANDACurrent
45802-366testosteronetestosteronePerrigo New York IncANDACurrent
45802-366testosteronetestosteronePerrigo New York IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50049APPL2017-10-12
49008ORIG2017-07-18
48990ORIG2017-07-14