FDA.reportPublic FDA data

Application 207521

Type
ANDA
Sponsor
SOMERSET

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
70069-022Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent
70069-022Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent
70069-023Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent
70069-023Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent
70069-024Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent
70069-024Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateSomerset Therapeutics, LLCANDACurrent