FDA.reportPublic FDA data

Application 205483

Type
ANDA
Sponsor
AJANTA PHARMA LTD

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
27241-037solifenacin succinatesolifenacin succinateAjanta Pharma LimitedANDACurrent
27241-037solifenacin succinatesolifenacin succinateAjanta Pharma LimitedANDACurrent
27241-037solifenacin succinatesolifenacin succinateAjanta Pharma LimitedANDACurrent
27241-037solifenacin succinatesolifenacin succinateAjanta Pharma USA Inc.ANDACurrent
27241-038solifenacin succinatesolifenacin succinateAjanta Pharma LimitedANDACurrent
27241-038solifenacin succinatesolifenacin succinateAjanta Pharma LimitedANDACurrent
27241-038solifenacin succinatesolifenacin succinateAjanta Pharma LimitedANDACurrent
27241-038solifenacin succinatesolifenacin succinateAjanta Pharma USA Inc.ANDACurrent