FDA.reportPublic FDA data

Application 212287

Type
ANDA
Sponsor
ASTRAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALNoNo
002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALNoNo
003PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMINJECTABLE;INJECTIONEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
66794-216Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-216Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-216Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-216Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-216Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-216Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-216Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-217Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-217Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-217Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-217Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-217Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-217Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-217Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-218Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-218Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-218Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-218Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-218Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-218Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
66794-218Piperacillin and TazobactamPiperacillin and TazobactamPiramal Critical Care IncANDACurrent
70594-078PIPERACILLIN SODIUM and TAZOBACTAM SODIUMPIPERACILLIN SODIUM and TAZOBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-078PIPERACILLIN SODIUM and TAZOBACTAM SODIUMPIPERACILLIN SODIUM and TAZOBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-078PIPERACILLIN SODIUM and TAZOBACTAM SODIUMPIPERACILLIN SODIUM and TAZOBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-079PIPERACILLIN SODIUM and TAZOBACTAM SODIUMPIPERACILLIN SODIUM and TAZOBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-079PIPERACILLIN SODIUM and TAZOBACTAM SODIUMPIPERACILLIN SODIUM and TAZOBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-079PIPERACILLIN SODIUM and TAZOBACTAM SODIUMPIPERACILLIN SODIUM and TAZOBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-080PIPERACILLIN SODIUM and TAZOBACTAM SODIUMPIPERACILLIN SODIUM and TAZOBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-080PIPERACILLIN SODIUM and TAZOBACTAM SODIUMPIPERACILLIN SODIUM and TAZOBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
70594-080PIPERACILLIN SODIUM and TAZOBACTAM SODIUMPIPERACILLIN SODIUM and TAZOBACTAM SODIUMXellia Pharmaceuticals USA LLCANDACurrent
71288-002Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-002Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-002Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-003Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-003Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-003Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-004Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-004Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
71288-004Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumMeitheal Pharmaceuticals Inc.ANDACurrent
72572-575Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumCivica, Inc.ANDACurrent
72572-575Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumCivica, Inc.ANDACurrent
72572-576Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumCivica, Inc.ANDACurrent
72572-576Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumCivica, Inc.ANDACurrent
72572-577Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumCivica, Inc.ANDACurrent
72572-577Piperacillin and TazobactamPiperacillin Sodium and Tazobactam SodiumCivica, Inc.ANDACurrent