FDA.reportPublic FDA data

Application 208674

Type
ANDA
Sponsor
SAGENT PHARMS INC

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

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208674-001PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 2GM BASE/VIAL;EQ 250MG BASE/VIALINJECTABLE / INJECTIONAP2021-02-16
A208674-002PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 3GM BASE/VIAL;EQ 375MG BASE/VIALINJECTABLE / INJECTIONAP2021-02-16
A208674-003PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUMEQ 4GM BASE/VIAL;EQ 500MG BASE/VIALINJECTABLE / INJECTIONAP2021-02-16

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A208674-001AP
A208674-002AP
A208674-003AP

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMWG Critical Care, LLC17a400ae-cbaa-4d07-95f4-c6917dfc05852026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMCivica, Inc.19e89f8b-316b-4dd2-9724-bfe0faeba4082025-12-12Warnings, Adverse reactionsName fallback
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMCivica, Inc.7aebc0e6-89db-4ef0-b5ab-d6b3199bcfc42025-09-08Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMAvenacy, LLC668a2730-e95a-4639-a506-ae95a6502ca12025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLC39e19789-de4b-4fd1-ab1c-92f59496f4962025-08-19Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMEugia US LLCa5d8625e-e630-4076-bc55-46ebe861c6a52025-08-08Warnings, Adverse reactionsName fallback
piperacillin and tazobactamPIPERACILLIN AND TAZOBACTAMONESOURCE SPECIALTY PHARMA LIMITED28258745-12e4-4f0f-b318-4a1a1bebc9282025-07-21Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMAvenacy, LLC9114cea1-3338-487e-87fa-cc3a409d501a2025-07-07Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMBluePoint Laboratories1aba753c-d0c2-4b35-917a-9143dd4be4682025-06-20Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMApotex Corp.2c8f06a2-49b2-4169-94ef-182d13d248bf2025-05-21Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCc5cddf50-e486-4ffb-9bc6-ed67ad6bc1542025-04-14Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCa798faf5-cd97-4e35-a700-94c372978c462025-04-14Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLC6a894b94-171f-4217-81a2-0e84796b0b412025-04-11Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMFresenius Kabi USA, LLCc8e3cc43-238d-4a23-95dc-157c85f831842025-04-10Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMProvepharm Inc.68d5384d-1691-4afc-8a1a-488f8e2ef2c52025-02-26Boxed warning, Warnings, Adverse reactionsName fallback
PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM AND TAZOBACTAM SODIUMProvepharm Inc.bc26ffd8-1a6e-4e16-91c1-ec67c928b3bf2025-02-26Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMSandoz Inc9b682c66-61c6-4ade-baf4-9d68911a16b82024-10-30Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMHospira, Inc4d3f4b69-b0b9-494f-9cda-4537fa420d472024-10-25Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN AND TAZOBACTAMShandong Anxin Pharmaceutical Co., Ltd.420196a5-f62d-473f-84d8-d7fc3f31c3d32024-10-17Warnings, Adverse reactionsName fallback
Piperacillin and TazobactamPIPERACILLIN SODIUM,TAZOBACTAM SODIUMFresenius Kabi USA, LLCfc4d1e35-23eb-4654-8691-ae5bfd50a48a2024-10-16Warnings, Adverse reactionsName fallback

Boxed warning cross-check#

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boxed warning

PHARMACY BULK PACKAGE-NOT FOR DIRECT INFUSION

Warnings cross-check#

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warnings and cautions

5 WARNINGS AND PRECAUTIONS • Serious hypersensitivity reactions (anaphylactic/anaphylactoid) have been reported in patients receiving piperacillin and tazobactam. Discontinue piperacillin and tazobactam if a reaction occurs. ( 5.1 ) • Piperacillin and tazobactam for injection may cause severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis. Discontinue piperacillin and tazobactam for injection for progressive rashes. ( 5.2 ) • Hemophagocytic lymphohistiocytosis (HLH) has been reported with the use of piperacillin and tazobactam. If HLH is suspected, discontinue piperacillin and tazobactam immediately. ( 5.3 ) • Rhabdomyolysis: If signs or symptoms of rhabdomyolysis are observed, discontinue Piperacillin and tazobactam for injection and initiate appropriate therapy. (5.4) • Hematological effects (including bleeding, leukopenia and neutropenia) have occurred. Monitor hematologic tests during prolonged therapy. ( 5.5 ) • As with other penicillins, piperacillin and tazobactam may cause neuromuscular excitability or seizures. Patients receiving higher doses, especially in the presence of renal impairment may be at greater risk. Closely monitor patients with renal impairment or seizure disorders for signs and symptoms of neuromuscular excitability or seizures. ( 5.6 ) • Nephrotoxicity in critically ill patients has been observed; the use of piperacillin and tazobactam was found to be an independent risk factor for renal failure and was associated with delayed recovery of renal function as compared to other beta-lactam antibacterial drugs in a randomized, multicenter, controlled trial in critically ill patients. Based on this study, alternative treatment options should be considered in the critically ill population. If alternative treatment options are inadequate or unavailable, monitor renal function during treatment with piperacillin and tazobactam for injection. ( 5.7 ) • Clostridioides difficile associated diarrhea: evaluate patients if diarrhea occurs. ( 5.9 ) 5.1 Hypersensitivity Adverse Reactions Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions (including shock) have been reported in patients receiving therapy with piperacillin and tazobactam for injection. These reactions ar...

Adverse reactions cross-check#

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adverse reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypersensitivity Adverse Reactions [see Warnings and Precautions ( 5.1 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] • Hemophagocytic Lymphohistiocytosis [see Warnings and Precautions ( 5.3 )] • Rhabdomyolysis [ see Warnings and Precautions (5.4) ] • Hematologic Adverse Reactions [see Warnings and Precautions ( 5.5 )] • Central Nervous System Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Nephrotoxicity in Critically Ill Patients [see Warnings and Precautions ( 5.7 )] • Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions ( 5.9 )] The most common adverse reactions (incidence >5%) are diarrhea, constipation, nausea, headache and insomnia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact WG Critical Care, LLC at 1-866-562-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Adult Patients During the initial clinical investigations, 2621 patients worldwide were treated with piperacillin and tazobactam in phase 3 trials. In the key North American monotherapy clinical trials (n=830 patients), 90% of the adverse events reported were mild to moderate in severity and transient in nature. However, in 3.2% of the patients treated worldwide, piperacillin and tazobactam was discontinued because of adverse events primarily involving the skin (1.3%), including rash and pruritus; the gastrointestinal system (0.9%), including diarrhea, nausea, and vomiting; and allergic reactions (0.5%). Table 6. Adverse Reactions from Piperacillin and Tazobactam Monotherapy Clinical Trials System Organ Class Adverse Reaction Gastrointestinal disorders Diarrhea (11.3%) Constipation (7.7%) Nausea (6.9%) Vomiting (3.3%) Dyspepsia (3.3%) Abdominal pain (1.3%) General disorders and administration site conditions Fever (2.4%) Injection site reaction (≤1%) Rigors (≤1%) Immune system disorders Anaphylaxis (≤1%) Infections and infestations Candidiasis (1.6%) Pseudomembranous colitis (≤1%) Metabolism...

adverse reactions table

Table 6. Adverse Reactions from Piperacillin and Tazobactam Monotherapy Clinical TrialsSystem Organ Class Adverse ReactionGastrointestinal disorders Diarrhea (11.3%) Constipation (7.7%) Nausea (6.9%) Vomiting (3.3%) Dyspepsia (3.3%) Abdominal pain (1.3%) General disorders and administration site conditions Fever (2.4%) Injection site reaction (≤1%) Rigors (≤1%)Immune system disorders Anaphylaxis (≤1%)Infections and infestations Candidiasis (1.6%) Pseudomembranous colitis (≤1%)Metabolism and nutrition disorders Hypoglycemia (≤1%)Musculoskeletal and connective tissue disorders Myalgia(≤1%) Arthralgia (≤1%)Nervous system disorders Headache (7.7%) Psychiatric disordersInsomnia (6.6%)Skin and subcutaneous tissue disorders Rash (4.2%, including maculopapular, bullous, and urticarial) Pruritus (3.1%) Purpura (≤1%)Vascular disorders Phlebitis (1.3%) Thrombophlebitis (≤1%) Hypotension (≤1%) Flushing (≤1%)Respiratory, thoracic and mediastinal disordersEpistaxis (≤1%)

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25021-175Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-175Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-176Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-176Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-177Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent
25021-177Piperacillin, TazobactamPiperacillin Sodium, Tazobactam SodiumSagent PharmaceuticalsANDACurrent