FDA.reportPublic FDA data

Application 208690

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREEDEXAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTIONEQ 10MG PHOSPHATE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1399Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1399Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1399Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Biosciences LLCANDACurrent
70121-1399Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent