Tis-U-Sol

NDA 18508, held by Baxter Hlthcare. Magnesium Sulfate; Potassium Chloride; Potassium Phosphate, Monobasic; Sodium Chloride; Sodium Phosphate.

As of Nov 14, 2026, NDA 18508 (Tis-U-Sol), held by Baxter Hlthcare, was first approved by FDA on Feb 19, 1982, with 13 approved supplements and 0 published complete response letters.

First approved: Feb 19, 1982
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Isotonic solution for irrigation only. Not for injection.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Feb 19, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Tis-U-Sol20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML · solution;irrigation	Magnesium Sulfate; Potassium Chloride; Potassium Phosphate, Monobasic; Sodium Chloride; Sodium Phosphate	Rx

All 14 submissions, including labeling and manufacturing supplements


Jun 26, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Feb 3, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
Sep 28, 2011	Supplement 19Manufacturing	Approved	None posted
Sep 30, 1994	Supplement 12Manufacturing · Standard review	Approved	None posted
Sep 14, 1993	Supplement 13Manufacturing · Standard review	Approved	None posted
Nov 14, 1991	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 26, 1991	Supplement 11Manufacturing · Standard review	Approved	None posted
May 18, 1990	Supplement 9Manufacturing · Standard review	Approved	None posted
Jul 26, 1989	Supplement 8Manufacturing · Standard review	Approved	None posted
Oct 30, 1986	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 26, 1985	Supplement 6Labeling	Approved	None posted
Jan 24, 1985	Supplement 2Manufacturing · Standard review	Approved	None posted
Feb 28, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 19, 1982	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18508
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