FDA.reportPublic FDA data

Application 078352

Type
ANDA
Sponsor
LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESLORATADINEDESLORATADINETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4794DESLORATADINEDESLORATADINEA-S Medication SolutionsANDACurrent
50090-4794DESLORATADINEDESLORATADINEA-S Medication SolutionsANDACurrent
50090-4794DESLORATADINEDESLORATADINEA-S Medication SolutionsANDACurrent
68180-153DESLORATADINEDESLORATADINELupin Pharmaceuticals, Inc.ANDACurrent
68180-153DESLORATADINEDESLORATADINELupin Pharmaceuticals, Inc.ANDACurrent
68180-153DESLORATADINEDESLORATADINELupin Pharmaceuticals, InANDACurrent
71335-1000DESLORATADINEDESLORATADINEBryant Ranch PrepackANDACurrent
71335-1000DESLORATADINEDESLORATADINEBryant Ranch PrepackANDACurrent