Application 208560

Type
ANDA
Sponsor
LUPIN ATLANTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONETESTOSTERONEGEL, METERED;TRANSDERMAL1.62% (20.25MG/1.25GM ACTUATION)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68180-941TestosteroneTestosteroneLupin Pharmaceuticals, Inc.ANDACurrent
68180-941TestosteroneTestosteroneLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54163ORIG2018-05-11