FDA.reportPublic FDA data

Application 065406

Type
ANDA
Sponsor
ACS DOBFAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 500MG BASE/VIALNoNo
002AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6116Ampicillin and SulbactamAmpicillin and SulbactamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6116Ampicillin and SulbactamAmpicillin and SulbactamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6117Ampicillin and SulbactamAmpicillin and SulbactamWest-Ward Pharmaceuticals Corp.ANDACurrent
0641-6117Ampicillin and SulbactamAmpicillin and SulbactamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6119Ampicillin and SulbactamAmpicillin and SulbactamWest-Ward Pharmaceutical Corp.ANDACurrent
0641-6119Ampicillin and SulbactamAmpicillin and SulbactamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6120Ampicillin and SulbactamAmpicillin and SulbactamWest-Ward Pharmaceutical Corp.ANDACurrent
0641-6120Ampicillin and SulbactamAmpicillin and SulbactamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6122Ampicillin and SulbactamAmpicillin and SulbactamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6122Ampicillin and SulbactamAmpicillin and SulbactamWest-ward Pharmaceutical Corp.ANDACurrent
0641-6123Ampicillin and SulbactamAmpicillin and SulbactamHikma Pharmaceuticals USA Inc.ANDACurrent
0641-6123Ampicillin and SulbactamAmpicillin and SulbactamWest-ward Pharmaceutical Corp.ANDACurrent
25021-142ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent
25021-142ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent
25021-142ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent
25021-142ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent
25021-143ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent
25021-143ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent
25021-143ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent
25021-143ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent