FDA.reportPublic FDA data

Application 213200

Type
ANDA
Sponsor
RISING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001URSODIOLURSODIOLCAPSULE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42385-946UrsodiolUrsodiolLaurus Labs LimitedANDACurrent
64980-483UrsodiolUrsodiolRising Pharmaceuticals, Inc.ANDACurrent