Sutab

NDA 213135, held by Azurity. Magnesium Sulfate; Potassium Chloride; Sodium Sulfate.

As of Nov 14, 2026, NDA 213135 (Sutab), held by Azurity, was first approved by FDA on Nov 10, 2020, with 2 approved supplements and 1 published complete response letter.

First approved: Nov 10, 2020
Review: Standard
Supplements approved: 2
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

SUTAB is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. SUTAB is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Nov 10, 2020	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Mar 13, 2020	NDA 213135Product Quality/Facility Inspection Deficiencies	Approved

Products

1 strengths and forms

Product	Active ingredient	Marketing
Sutab0.225GM;0.188GM;1.479GM · tablet;oral	Magnesium Sulfate; Potassium Chloride; Sodium Sulfate	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


Oct 24, 2023	Supplement 4Labeling · Standard review	Approved	Label Medication Guide Letter
Jan 28, 2022	Supplement 3Labeling · Standard review	Approved	Letter Label
Nov 10, 2020	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 213135
Drugs@FDA: Overview at FDA
Company: Azurity Pharmaceuticals

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