Application 210966

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-304Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAuroMedics Pharma LLCANDACurrent
55150-304Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAuroMedics Pharma LLCANDACurrent