FDA.reportPublic FDA data

Application 075183

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1411Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateA-S Medication SolutionsANDACurrent
50383-040Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-040Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-040Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateAkornANDACurrent
50383-040Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateHi-Tech Pharmacal Co., Inc.ANDACurrent