FDA.reportPublic FDA data

Application 078465

Type
ANDA
Sponsor
PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATESOLUTION;ORALEQ 10MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0773Prednisolone Sodium PhosphatePrednisolone Sodium PhosphatePharmaceutical Associates, Inc.ANDACurrent
0121-0773Prednisolone Sodium PhosphatePrednisolone Sodium PhosphatePharmaceutical Associates, Inc.ANDACurrent
0121-0773Prednisolone Sodium PhosphatePrednisolone Sodium PhosphatePharmaceutical Associates, Inc.ANDACurrent
23594-510MillipredPREDNISOLONE SODIUM PHOSPHATEZylera Pharmaceuticals, LANDACurrent
23594-510MillipredPREDNISOLONE SODIUM PHOSPHATECerecor, Inc.ANDACurrent