FDA.reportPublic FDA data

Application 063315

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMIKACIN SULFATEAMIKACIN SULFATEINJECTABLE;INJECTIONEQ 250MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6166Amikacin SulfateAmikacin SulfateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6166Amikacin SulfateAmikacin SulfateHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6167Amikacin SulfateAmikacin SulfateWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6167Amikacin SulfateAmikacin SulfateHikma Pharmaceuticals USA Inc.ANDACurrent