FDA.reportPublic FDA data

Application 076895

Type
ANDA
Sponsor
WOCKHARDT BIO AG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATESOLUTION;ORALEQ 15MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0955Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateA-S Medication SolutionsANDACurrent
60432-212Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateMorton Grove Pharmaceuticals, Inc.ANDACurrent
60432-212Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateMorton Grove Pharmaceuticals, Inc.ANDACurrent