All FDA drug approvals

FDA approval · Drugs@FDA

PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINERpiperacillin sodium, tazobactam sodium

NDA206056 ·

FDA approved the original new drug application for PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER on April 3, 2025, sponsored by B BRAUN MEDICAL. FDA’s record shows no approved efficacy supplement on the application since.

Application
NDA206056
Sponsor
B BRAUN MEDICAL
Original approval
Review
standard review
Submission class
Type 5 - New Formulation or New Manufacturer
Active ingredient
piperacillin sodium, tazobactam sodium

Products under this application

Ingredient and strengthFormRouteMarketing status
piperacillin sodium EQ 3GM BASE/VIAL; tazobactam sodium EQ 375MG BASE/VIALPOWDERINTRAVENOUSPrescription
piperacillin sodium EQ 4GM BASE/VIAL; tazobactam sodium EQ 500MG BASE/VIALPOWDERINTRAVENOUSPrescription
piperacillin sodium EQ 2GM BASE/VIAL; tazobactam sodium EQ 250MG BASE/VIALPOWDERINTRAVENOUSPrescription

Approved efficacy supplements

An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.

FDA’s record shows no approved efficacy supplement on this application.

Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.

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