FDA.reportPublic FDA data

Application 202691

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9850Methylprednisolone Sodium SuccinateMethylprednisolone Sodium SuccinateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9850Methylprednisolone Sodium SuccinateMethylprednisolone Sodium SuccinateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9850Methylprednisolone Sodium SuccinateMethylprednisolone Sodium SuccinateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9851Methylprednisolone Sodium SuccinateMethylprednisolone Sodium SuccinateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9851Methylprednisolone Sodium SuccinateMethylprednisolone Sodium SuccinateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9851Methylprednisolone Sodium SuccinateMethylprednisolone Sodium SuccinateHikma Pharmaceuticals USA Inc.ANDACurrent