Application 062251

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENTAMICIN SULFATEGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 40MG BASE/MLNoNo
002GENTAMICIN SULFATEGENTAMICIN SULFATEINJECTABLE;INJECTIONEQ 10MG BASE/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9128GentamicinGentamicinHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9129GentamicinGentamicinHikma Pharmaceuticals USA Inc.ANDACurrent