FDA.reportPublic FDA data

Application 084282

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

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
0641-6145Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6145Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6146Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6146Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateHikma Pharmaceuticals USA Inc.ANDACurrent
51662-1297DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1297DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1297DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1297DEXAMETHASONE SODIUM PHOSPHATEDEXAMETHASONE SODIUM PHOSPHATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
70518-3458Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateREMEDYREPACK INC.ANDACurrent
71872-7164Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMedical Purchasing Solutions, LLCANDACurrent
71872-7171Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateMedical Purchasing Solutions, LLCANDACurrent
72572-120Dexamethasone Sodium PhosphateDexamethasone Sodium PhosphateCivica, Inc.ANDACurrent