FDA.reportPublic FDA data

Application 090579

Type
ANDA
Sponsor
ASTRAL

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
25021-186ampicillin and sulbactamampicillin sodium and sulbactam sodiumSagent PharmaceuticalsANDACurrent
25021-186ampicillin and sulbactamampicillin sodium and sulbactam sodiumSagent PharmaceuticalsANDACurrent
25021-187ampicillin and sulbactamampicillin sodium and sulbactam sodiumSagent PharmaceuticalsANDACurrent
25021-187ampicillin and sulbactamampicillin sodium and sulbactam sodiumSagent PharmaceuticalsANDACurrent
66794-206ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-206ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-206ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-206ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-206ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-206ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-206ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-207ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-207ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-207ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-207ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-207ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-207ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
66794-207ampicillin and sulbactamampicillin and sulbactamPiramal Critical Care IncANDACurrent
70594-081Ampicillin and SulbactamAMPICILLIN SODIUM and SULBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-081Ampicillin and SulbactamAMPICILLIN SODIUM and SULBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-082Ampicillin and SulbactamAMPICILLIN SODIUM and SULBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-082Ampicillin and SulbactamAMPICILLIN SODIUM and SULBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
71288-005Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-005Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-005Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-006Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-006Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-006Ampicillin and SulbactamAmpicillin sodium and Sulbactam sodiumMeitheal Pharmaceuticals Inc.ANDACurrent
72572-021Ampicillin and SulbactamAmpicillin and SulbactamCivica, Inc.ANDACurrent
72572-021Ampicillin and SulbactamAmpicillin and SulbactamCivica, Inc.ANDACurrent
72572-022Ampicillin and SulbactamAmpicillin and SulbactamCivica, Inc.ANDACurrent
72572-022Ampicillin and SulbactamAmpicillin and SulbactamCivica, Inc.ANDACurrent