FDA approval · Drugs@FDA
PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDEpantoprazole sodium
NDA217512 ·
FDA approved the original new drug application for PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE on February 14, 2024, sponsored by BAXTER HLTHCARE CORP. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- NDA217512
- Sponsor
- BAXTER HLTHCARE CORP
- Original approval
- Review
- standard review
- Submission class
- Type 3 - New Dosage Form
- Active ingredient
- pantoprazole 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 |
|---|---|---|---|
| pantoprazole sodium EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
| pantoprazole sodium EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) | SOLUTION | INTRAVENOUS | Prescription |
| pantoprazole sodium EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) | SOLUTION | 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.
Other approvals to BAXTER HLTHCARE CORP
- August 14, 2026SODIUM BICARBONATENDA218524
- March 30, 2026EPINEPHRINENDA220626
- February 28, 2025EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDENDA218475
- September 29, 2023VASOPRESSIN IN SODIUM CHLORIDE 0.9%NDA217569
- September 29, 2023MICAFUNGIN IN SODIUM CHLORIDE 0.9%NDA216142
- June 27, 2023CYCLOPHOSPHAMIDENDA217651
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