Miralax

NDA 22015, held by Bayer Healthcare LLC. Polyethylene Glycol 3350.

As of Nov 14, 2026, NDA 22015 (Miralax), held by Bayer Healthcare LLC, was first approved by FDA on Oct 6, 2006, with 28 approved supplements and 0 published complete response letters.

First approved: Oct 6, 2006
Review: Standard
Supplements approved: 28
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Use

relieves occasional constipation (irregularity)
generally produces a bowel movement in 1 to 3 days

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 29 submissions below

Date	Submission	Status	Documents
Oct 6, 2006	Original applicationTYPE 8 · Standard review	Approved	Review Letter

Products

2 strengths and forms


Miralax17GM/SCOOPFUL · for solution;oral	Polyethylene Glycol 3350	OTCReference drug
Miralax17GM/PACKET · for solution;oral	Polyethylene Glycol 3350	OTCReference drug

All 29 submissions, including labeling and manufacturing supplements


Nov 6, 2026	Supplement 51Labeling · Standard review	Approved	Label Letter
Feb 3, 2025	Supplement 50Labeling · Standard review	Approved	Label Letter
Sep 18, 2023	Supplement 48Labeling · Standard review	Approved	Label Letter
Jul 27, 2023	Supplement 47Labeling · Standard review	Approved	Label Letter
Jun 20, 2023	Supplement 46Labeling · Standard review	Approved	Label Letter
Mar 23, 2023	Supplement 45Labeling · Standard review	Approved	Label Letter
Jul 5, 2022	Supplement 43Labeling · Standard review	Approved	Letter Label
Apr 27, 2021	Supplement 40Labeling · Standard review	Approved	Label Letter
Jun 3, 2019	Supplement 35Labeling · Standard review	Approved	Label Letter
Oct 12, 2018	Supplement 34Labeling · Standard review	Approved	Letter Label
Aug 17, 2018	Supplement 33Labeling · Standard review	Approved	Label Letter
May 4, 2018	Supplement 30Labeling · Standard review	Approved	Letter Label
Apr 24, 2018	Supplement 29Labeling · Standard review	Approved	Label Letter
Oct 4, 2017	Supplement 27Labeling · Standard review	Approved	Label Letter
Oct 21, 2016	Supplement 26Labeling · Standard review	Approved	Label Letter
Sep 30, 2016	Supplement 25Labeling · Standard review	Approved	Label Letter
Nov 12, 2015	Supplement 24Labeling · Standard review	Approved	Label Letter
Oct 29, 2015	Supplement 23Labeling · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 18Manufacturing · Standard review	Approved	None posted
Jul 14, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Aug 3, 2014	Supplement 20Manufacturing · Standard review	Approved	Letter Label
Mar 5, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Oct 22, 2013	Supplement 17Manufacturing · Standard review	Approved	None posted
Jan 4, 2013	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 15, 2012	Supplement 12Labeling · Standard review	Approved	Letter
May 5, 2010	Supplement 6Labeling · Standard review	Approved	Letter
Dec 2, 2008	Supplement 3Manufacturing	Approved	Letter
Nov 20, 2008	Supplement 2Manufacturing	Approved	Letter
Oct 6, 2006	Original applicationTYPE 8 · Standard review	Approved	Review Letter

Identifiers

Application: NDA 22015
Drugs@FDA: Overview at FDA
Company: Bayer 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