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
Browse every approval whose brand starts with P, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| piperacillin sodium EQ 3GM BASE/VIAL; tazobactam sodium EQ 375MG BASE/VIAL | POWDER | INTRAVENOUS | Prescription |
| piperacillin sodium EQ 4GM BASE/VIAL; tazobactam sodium EQ 500MG BASE/VIAL | POWDER | INTRAVENOUS | Prescription |
| piperacillin sodium EQ 2GM BASE/VIAL; tazobactam sodium EQ 250MG BASE/VIAL | POWDER | INTRAVENOUS | Prescription |
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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