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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 206996


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NDA 206996 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 206996
Pharmacology for NDA: 206996
Mechanism of Actionbeta Lactamase Inhibitors
Suppliers and Packaging for NDA: 206996
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 206996 ANDA Wockhardt USA LLC. 64679-012 64679-012-01 10 VIAL, SINGLE-USE in 1 CARTON (64679-012-01) / 20 mL in 1 VIAL, SINGLE-USE (64679-012-02)
PIPERACILLIN AND TAZOBACTAM piperacillin sodium; tazobactam sodium INJECTABLE;INJECTION 206996 ANDA Wockhardt USA LLC. 64679-034 64679-034-01 10 VIAL, SINGLE-USE in 1 CARTON (64679-034-01) / 10 mL in 1 VIAL, SINGLE-USE (64679-034-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL
Approval Date:Mar 22, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL
Approval Date:Mar 22, 2017TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL
Approval Date:Mar 22, 2017TE:APRLD:No

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