Application 213922

Type
ANDA
Sponsor
ALEOR DERMACEUTICALS

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
62332-552TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals, Inc.ANDACurrent
62332-552TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals, Inc.ANDACurrent
62332-552TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals, Inc.ANDACurrent
71589-011TESTOSTERONETESTOSTERONEAleor Dermaceuticals LimitedANDACurrent
71589-011TESTOSTERONETESTOSTERONEAleor Dermaceuticals LimitedANDACurrent