FDA.reportPublic FDA data

Application 078345

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-102Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateRebel Distributors CorpANDACurrent
65162-667Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateAmneal Pharmaceuticals of New York, LLCANDACurrent
65162-667Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
65162-667Prednisolone Sodium PhosphatePrednisolone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent