FDA.reportPublic FDA data

Application 211036

Type
ANDA
Sponsor
SOMERSET THERAPS LLC

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
70069-025DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATESomerset Therapeutics, LLCANDACurrent
70069-025DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATESomerset Therapeutics, LLCANDACurrent
70069-025DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATESomerset Therapeutics, LLCANDACurrent
71872-7205DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEMedical Purchasing Solutions, LLCANDACurrent