FDA.reportPublic FDA data

Application 091396

Type
ANDA
Sponsor
MISSION PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISOLONE SODIUM PHOSPHATEPREDNISOLONE SODIUM PHOSPHATESOLUTION;ORALEQ 25MG BASE/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0178-0582Prednisolone Sodium Phosphate Oral SolutionPrednisolone Sodium PhosphateMission Pharmacal CompanyANDACurrent
44523-182Prednisolone Sodium Phosphate Oral SolutionPrednisolone Sodium PhosphateBioComp Pharma, Inc.ANDACurrent
44523-182Prednisolone Sodium Phosphate Oral SolutionPrednisolone Sodium PhosphateBioComp Pharma, Inc.ANDACurrent
44523-182Prednisolone Sodium Phosphate Oral SolutionPrednisolone Sodium PhosphateBioComp Pharma, Inc.ANDACurrent