Pantoprazole Sodium In 0.9% Sodium Chloride

NDA 217512, held by Baxter Hlthcare Corp. Pantoprazole Sodium.

As of Nov 13, 2026, NDA 217512 (Pantoprazole Sodium In 0.9% Sodium Chloride), held by Baxter Hlthcare Corp, was first approved by FDA on Feb 14, 2024, with 0 approved supplements and 0 published complete response letters.

First approved: Feb 14, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Pantoprazole sodium is a proton pump inhibitor (PPI) indicated in adults for the following:

Short-term treatment (7 to 10 days) of gastroesophageal reflux disease (GERD) associated with a history of Erosive Esophagitis (EE).
Pathological hypersecretion conditions including Zollinger-Ellison (ZE) Syndrome. 1.1 Gastroesophageal Reflux Disease Associated with a History of Erosive Esophagitis Pantoprazole sodium in 0.9% sodium chloride injection is indicated for short-term treatment (7 to 10 days) of adult patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis (EE). Safety and efficacy of pantoprazole sodium in 0.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Feb 14, 2024	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

3 strengths and forms

Product	Active ingredient	Marketing
Pantoprazole Sodium In 0.9% Sodium ChlorideEQ 40MG BASE/100ML (EQ 0.4MG BASE/ML) · solution;intravenous	Pantoprazole Sodium	RxReference drug
Pantoprazole Sodium In 0.9% Sodium ChlorideEQ 40MG BASE/50ML (EQ 0.8MG BASE/ML) · solution;intravenous	Pantoprazole Sodium	RxReference drug
Pantoprazole Sodium In 0.9% Sodium ChlorideEQ 80MG BASE/100ML (EQ 0.8MG BASE/ML) · solution;intravenous	Pantoprazole Sodium	RxReference drug

Identifiers

Application: NDA 217512
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters