FDA.reportPublic FDA data

Application 040425

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATETABLET;ORAL0.1MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0997Fludrocortisone AcetateFludrocortisone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0997Fludrocortisone AcetateFludrocortisone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0997Fludrocortisone AcetateFludrocortisone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0997Fludrocortisone AcetateFludrocortisone AcetateTeva Pharmaceuticals USA, Inc.ANDACurrent
43063-714Fludrocortisone AcetateFludrocortisone AcetatePD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-7780Fludrocortisone AcetateFludrocortisone AcetateBryant Ranch PrepackANDACurrent
63629-7780Fludrocortisone AcetateFludrocortisone AcetateBryant Ranch PrepackANDACurrent
63629-8806Fludrocortisone AcetateFludrocortisone AcetateBryant Ranch PrepackANDACurrent
63629-8806Fludrocortisone AcetateFludrocortisone AcetateBryant Ranch PrepackANDACurrent