Nulytely, Nulytely-Flavored

NDA 19797, held by Azurity. Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride.

As of Nov 13, 2026, NDA 19797 (Nulytely, Nulytely-Flavored), held by Azurity, was first approved by FDA on Apr 22, 1991, with 17 approved supplements and 0 published complete response letters.

First approved: Apr 22, 1991
Review: Standard
Supplements approved: 17
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is indicated for bowel cleansing prior to colonoscopy in adults and pediatric patients aged 6 months or greater. PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy in adults and pediatric patients aged 6 months or greater

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Apr 22, 1991	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Nulytely420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug
Nulytely-Flavored420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride	RxReference drug

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
May 14, 2021	Supplement 29Labeling · Standard review	Approved	Label Letter
Sep 23, 2013	Supplement 22Labeling · Standard review	Approved	Letter Label
Jan 27, 2010	Supplement 18Labeling · Standard review	Approved	None posted
Aug 7, 2003	Supplement 14Manufacturing · Standard review	Approved	None posted
Jun 30, 2003	Supplement 13Manufacturing · Standard review	Approved	Letter
Feb 23, 2001	Supplement 12Manufacturing · Standard review	Approved	None posted
Jan 28, 2000	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 13, 1999	Supplement 9Manufacturing · Standard review	Approved	None posted
Oct 9, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Mar 25, 1999	Supplement 8Manufacturing · Standard review	Approved	None posted
Dec 10, 1997	Supplement 7Labeling · Standard review	Approved	None posted
Dec 10, 1997	Supplement 6Labeling · Standard review	Approved	None posted
Jun 3, 1997	Supplement 5Manufacturing · Standard review	Approved	None posted
Nov 4, 1996	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 2, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Nov 18, 1994	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 29, 1993	Supplement 1Manufacturing · Standard review	Approved	None posted
Apr 22, 1991	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 19797
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