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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 203557


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NDA 203557 describes PIPERACILLIN AND TAZOBACTAM, which is a drug marketed by Astral, Eugia Pharma, Eugia Pharma Speclts, Fresenius Kabi, Fresenius Kabi Usa, Hospira Inc, Istituto Bio Ita Spa, Provepharm Sas, Sagent Pharms Inc, Sandoz, Shandong, Steriscience Speclts, and Wockhardt Bio Ag, and is included in twenty-two NDAs. It is available from fourteen suppliers. Additional details are available on the PIPERACILLIN AND TAZOBACTAM profile page.

The generic ingredient in PIPERACILLIN AND TAZOBACTAM is piperacillin sodium; tazobactam sodium. There are sixteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the piperacillin sodium; tazobactam sodium profile page.
Summary for 203557
Pharmacology for NDA: 203557
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 203557
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 203557 ANDA Hospira, Inc 0409-2999 0409-2999-14 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-2999-14) / 60 mL in 1 VIAL, PHARMACY BULK PACKAGE
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 203557 ANDA Sandoz Inc 0781-3180 0781-3180-94 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3180-94) / 250 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL
Approval Date:Oct 29, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL
Approval Date:Jul 8, 2021TE:APRLD:No

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