FDA.reportPublic FDA data

Application 207847

Type
ANDA
Sponsor
APOLLO

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
39822-0123Piperacillin, TazobactamPiperacillin, TazobactamX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0123Piperacillin, TazobactamPiperacillin, TazobactamX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0125Piperacillin, TazobactamPiperacillin, TazobactamX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0125Piperacillin, TazobactamPiperacillin, TazobactamX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0127Piperacillin, TazobactamPiperacillin, TazobactamX-GEN Pharmaceuticals, Inc.ANDACurrent
39822-0127Piperacillin, TazobactamPiperacillin, TazobactamX-GEN Pharmaceuticals, Inc.ANDACurrent
61990-0110PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0110PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0110Piperacillin and TazobactamPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0110PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0120Piperacillin and TazobactamPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0120PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0120PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0120PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0130PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0130PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0130Piperacillin and TazobactamPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
61990-0130PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumApollo Pharmaceuticals Inc.ANDACurrent
81284-151PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumProvepharm Inc.ANDACurrent
81284-151PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumProvepharm Inc.ANDACurrent
81284-152PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumProvepharm Inc.ANDACurrent
81284-152PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumProvepharm Inc.ANDACurrent
81284-153PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumProvepharm Inc.ANDACurrent
81284-153PIPERACILLIN AND TAZOBACTAMPiperacillin sodium and Tazobactam sodiumProvepharm Inc.ANDACurrent