FDA.reportPublic FDA data

Application 208689

Type
ANDA
Sponsor
AMNEAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEINJECTABLE;INJECTIONEQ 4MG PHOSPHATE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70121-1450Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1450Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1450Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Biosciences LLCANDACurrent
70121-1450Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1451Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1451Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1451Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Biosciences LLCANDACurrent
70121-1451Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1452Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1452Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent
70121-1452Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Biosciences LLCANDACurrent
70121-1452Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAmneal Pharmaceuticals LLCANDACurrent