FDA.reportPublic FDA data

Application 210707

Type
ANDA
Sponsor
ABHAI LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10702-237UrsodiolUrsosiolKVK-Tech, Inc.ANDACurrent
10702-237UrsodiolUrsosiolKVK-Tech, Inc.ANDACurrent
43063-871UrsodiolUrsosiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-871UrsodiolUrsosiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-871UrsodiolUrsosiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-871UrsodiolUrsosiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-871UrsodiolUrsosiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-871UrsodiolUrsosiolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-871UrsodiolUrsosiolPD-Rx Pharmaceuticals, Inc.ANDACurrent