FDA.reportPublic FDA data

Application 090578

Type
ANDA
Sponsor
ASTRAL

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
25021-188ampicillin and sulbactamampicillin sodium and sulbactam sodiumSagent PharmaceuticalsANDACurrent
25021-188ampicillin and sulbactamampicillin and sulbactamSagent PharmaceuticalsANDACurrent
66794-208ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-208ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-208ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-208ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-208ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-208ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-208ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
70594-083Ampicillin and SulbactamAMPICILLIN SODIUM and SULBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-083Ampicillin and SulbactamAMPICILLIN SODIUM and SULBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-083Ampicillin and SulbactamAMPICILLIN SODIUM and SULBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
71288-007Ampicillin and SulbactamAmpicillin Sodium and Sulbactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-007Ampicillin and SulbactamAmpicillin Sodium and Sulbactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent