FDA.reportPublic FDA data

Application 207302

Type
ANDA
Sponsor
MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DARIFENACINDARIFENACIN HYDROBROMIDETABLET, EXTENDED RELEASE;ORALEQ 7.5MG BASENoNo
002DARIFENACINDARIFENACIN HYDROBROMIDETABLET, EXTENDED RELEASE;ORALEQ 15MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
33342-276DarifenacinDarifenacinMacleods Pharmaceuticals LimitedANDACurrent
33342-276DarifenacinDarifenacinMacleods Pharmaceuticals LimitedANDACurrent
33342-276DarifenacinDarifenacinMacleods Pharmaceuticals LimitedANDACurrent
33342-277DarifenacinDarifenacinMacleods Pharmaceuticals LimitedANDACurrent
33342-277DarifenacinDarifenacinMacleods Pharmaceuticals LimitedANDACurrent
33342-277DarifenacinDarifenacinMacleods Pharmaceuticals LimitedANDACurrent