FDA.reportPublic FDA data

Application 207442

Type
ANDA
Sponsor
SOMERSET THERAPS LLC

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
70069-021Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent
70069-021Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent
70069-021Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent
70069-021Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent