FDA.reportPublic FDA data

Application 201833

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM CHLORIDE 0.9%SODIUM CHLORIDEINJECTABLE;INJECTION9MG/MLNoNo
002SODIUM CHLORIDE 0.9%SODIUM CHLORIDESOLUTION;INJECTION90MG/10ML (9MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-0497Sodium ChlorideSodium ChlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-0497Sodium ChlorideSodium ChlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6144Sodium ChlorideSodium ChlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6144Sodium ChlorideSodium ChlorideWest-Ward Pharmaceuticals Corp.ANDACurrent