FDA.reportPublic FDA data

Application 204255

Type
ANDA
Sponsor
PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONETESTOSTERONESOLUTION, METERED;TRANSDERMAL30MG/1.5ML ACTUATIONNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-610testosteronetestosteronePadagis Israel Pharmaceuticals LtdANDACurrent
45802-610testosteronetestosteronePerrigo New York IncANDACurrent
45802-610testosteronetestosteronePerrigo New York IncANDACurrent
45802-610testosteronetestosteronePerrigo New York IncANDACurrent
63629-9310testosteronetestosteroneBryant Ranch PrepackANDACurrent
63629-9310testosteronetestosteroneBryant Ranch PrepackANDACurrent
63629-9310testosteronetestosteroneBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47484ORIG2017-03-08
47445ORIG2017-03-03