Golytely

NDA 19011, held by Azurity. Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous.

As of Nov 13, 2026, NDA 19011 (Golytely), held by Azurity, was first approved by FDA on Jul 13, 1984, with 20 approved supplements and 0 published complete response letters.

First approved: Jul 13, 1984
Review: Standard
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PEG-3350 and Electrolytes for Oral Solution is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults. PEG-3350 and Electrolytes for Oral Solution is a combination of PEG 3350, an osmotic laxative, and electrolytes indicated for cleansing of the colon in preparation for colonoscopy and barium enema X-ray examination in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 21 submissions below

Date	Submission	Status	Documents
Jul 13, 1984	Original applicationNew combination · Standard review	Approved	None posted

Products

2 strengths and forms


Golytely236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	RxReference drug
Golytely227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET · for solution;oral	Polyethylene Glycol 3350; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Sulfate Anhydrous	DiscontinuedReference drug

All 21 submissions, including labeling and manufacturing supplements


May 14, 2021	Supplement 33Labeling · Standard review	Approved	Label Medication Guide Letter
Jun 5, 2020	Supplement 31Labeling · Standard review	Approved	Label Other Letter
May 6, 2016	Supplement 27Manufacturing · Standard review	Approved	None posted
Jun 5, 2015	Supplement 26Manufacturing · Standard review	Approved	None posted
Sep 23, 2013	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 19, 2002	Supplement 15Labeling · Standard review	Approved	Letter
Feb 23, 2001	Supplement 14Manufacturing · Standard review	Approved	None posted
Oct 7, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Mar 25, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 3, 1997	Supplement 11Manufacturing · Standard review	Approved	None posted
Nov 4, 1996	Supplement 10Manufacturing · Standard review	Approved	None posted
Oct 30, 1995	Supplement 9Manufacturing · Standard review	Approved	None posted
Mar 24, 1993	Supplement 8Labeling · Standard review	Approved	None posted
Mar 24, 1993	Supplement 7Labeling · Standard review	Approved	None posted
Sep 17, 1992	Supplement 6Labeling · Standard review	Approved	None posted
Aug 20, 1992	Supplement 5Labeling	Approved	None posted
Jun 2, 1992	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 5, 1986	Supplement 3Labeling	Approved	None posted
Apr 19, 1985	Supplement 2Labeling	Approved	None posted
Feb 22, 1985	Supplement 1Labeling	Approved	None posted
Jul 13, 1984	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 19011
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