Application 212882

Type
ANDA
Sponsor
ALEOR DERMACEUTICALS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62332-488TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals, Inc.ANDACurrent
62332-488TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals, Inc.ANDACurrent
62332-488TESTOSTERONETESTOSTERONEAlembic Pharmaceuticals, Inc.ANDACurrent
71589-013TESTOSTERONETESTOSTERONEAleor Dermaceuticals LimitedANDACurrent
71589-013TESTOSTERONETESTOSTERONEAleor Dermaceuticals LimitedANDACurrent