FDA.reportPublic FDA data

Application 205550

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59746-516darifenacindarifenacin hydrobromideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-516darifenacindarifenacin hydrobromideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-517darifenacindarifenacin hydrobromideJubilant Cadista Pharmaceuticals Inc.ANDACurrent
59746-517darifenacindarifenacin hydrobromideJubilant Cadista Pharmaceuticals Inc.ANDACurrent