Application 204571

Type
ANDA
Sponsor
ACTAVIS LABS UT INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONETESTOSTERONEGEL, METERED;TRANSDERMAL10MG/0.5GM ACTUATIONNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2363TestosteronetestosteroneActavis Pharma, Inc.ANDACurrent
0591-2363TestosteronetestosteroneActavis Pharma, Inc.ANDACurrent
0591-2363TestosteronetestosteroneActavis Pharma, Inc.ANDACurrent
0591-2363TestosteronetestosteroneActavis Pharma, Inc.ANDACurrent
0591-2363TestosteronetestosteroneActavis Pharma, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24125ORIG2015-08-14
10357ORIG2015-08-10