FDA.reportPublic FDA data

Application 201850

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.9%SODIUM CHLORIDEINJECTABLE;INJECTION9MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-1512Sodium ChlorideSodium ChlorideWest-ward Pharmaceutical Corp.ANDACurrent
0641-1512Sodium ChlorideSodium ChlorideHikma Pharmaceuticals USA Inc.ANDACurrent