FDA.reportPublic FDA data

Application 211423

Type
ANDA
Sponsor
CSPC OUYI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATETABLET;ORAL5MGNoNo
002SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69844-047SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-047SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-047SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-048SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-048SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEGraviti Pharmaceuticals Private LimitedANDACurrent
69844-048SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATEGraviti Pharmaceuticals Private LimitedANDACurrent