FDA.reportPublic FDA data

Application 210967

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
51662-1541DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
55150-305Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAuroMedics Pharma LLCANDACurrent
55150-305Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateAuroMedics Pharma LLCANDACurrent
71872-7239Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMedical Purchasing Solutions, LLCANDACurrent