FDA.reportPublic FDA data

Application 065403

Type
ANDA
Sponsor
ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 10GM BASE/VIAL;EQ 5GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6118Ampicillin and SulbactamAmpicillin and SulbactamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6118Ampicillin and SulbactamAmpicillin and SulbactamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6121Ampicillin and SulbactamAmpicillin and SulbactamWest-Ward Pharmaceuticals Corp.ANDACurrent
25021-144ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent
25021-144ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent