FDA.reportPublic FDA data

Application 065523

Type
ANDA
Sponsor
ISTITUTO BIO ITA SPA

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
0781-3344Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumSandoz IncANDACurrent
0781-3350Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumSandoz IncANDACurrent
0781-3350Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumSandoz IncANDACurrent
0781-3367Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumSandoz IncANDACurrent
0781-3367Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumSandoz IncANDACurrent
0781-9344Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumSandoz IncANDACurrent
0781-9350Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumSandoz IncANDACurrent
0781-9350Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumSandoz IncANDACurrent
0781-9367Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumSandoz IncANDACurrent
44567-801Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-801Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-801Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-801Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-801Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-802Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-802Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-802Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-802Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-802Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-803Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-803Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-803Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-803Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
44567-803Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMWG Critical Care, LLCANDACurrent
63323-300Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-300Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-300Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-300Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-309Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-309Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-309Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-309Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-320Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-320Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-320Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
63323-320Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCANDACurrent
70860-120Piperacillin and Tazobactampiperacillin and tazobactamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-120Piperacillin and Tazobactampiperacillin and tazobactamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-120Piperacillin and Tazobactampiperacillin and tazobactamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-121Piperacillin and Tazobactampiperacillin and tazobactamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-121Piperacillin and Tazobactampiperacillin and tazobactamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-121Piperacillin and Tazobactampiperacillin and tazobactamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-122Piperacillin and Tazobactampiperacillin and tazobactamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-122Piperacillin and Tazobactampiperacillin and tazobactamAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-122Piperacillin and Tazobactampiperacillin and tazobactamAthenex Pharmaceutical Division, LLC.ANDACurrent
72572-573Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumCivica, Inc.ANDACurrent
72572-573Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumCivica, Inc.ANDACurrent
72572-573Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumCivica, Inc.ANDACurrent
72572-574Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumCivica, Inc.ANDACurrent
72572-574Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumCivica, Inc.ANDACurrent
72572-574Piperacillin and Tazobactampiperacillin sodium and tazobactam sodiumCivica, Inc.ANDACurrent