FDA approval · Drugs@FDA
ZOSYN IN PLASTIC CONTAINERpiperacillin sodium, tazobactam sodium
NDA050750 ·
FDA approved the original new drug application for ZOSYN IN PLASTIC CONTAINER on February 24, 1998, sponsored by BAXTER HLTHCARE CORP. FDA has approved 3 efficacy supplements on the application since, the most recent on May 26, 2020.
- Application
- NDA050750
- Sponsor
- BAXTER HLTHCARE CORP
- Original approval
- Review
- standard review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- piperacillin sodium, tazobactam sodium
Browse every approval whose brand starts with Z, 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 60MG BASE/ML; tazobactam sodium EQ 7.5MG BASE/ML | INJECTABLE | INJECTION | Prescription |
| piperacillin sodium EQ 4GM BASE/100ML; tazobactam sodium EQ 500MG BASE/100ML | INJECTABLE | INJECTION | Prescription |
| piperacillin sodium EQ 40MG BASE/ML; tazobactam sodium EQ 5MG BASE/ML | INJECTABLE | INJECTION | 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.
| Approved | Supplement | Review |
|---|---|---|
| S-8 | standard | |
| S-14 | standard | |
| S-43 | standard |
FDA records other approved supplements on this application, by the class code it assigns them: Labeling 26 · Manufacturing (CMC) 8. Those are changes to the label or to how the drug is made rather than new clinical evidence, so they are counted here and not listed.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
Other approvals to BAXTER HLTHCARE CORP
- August 14, 2026SODIUM BICARBONATENDA218524
- March 30, 2026EPINEPHRINENDA220626
- February 28, 2025EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDENDA218475
- February 14, 2024PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDENDA217512
- September 29, 2023VASOPRESSIN IN SODIUM CHLORIDE 0.9%NDA217569
- September 29, 2023MICAFUNGIN IN SODIUM CHLORIDE 0.9%NDA216142
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