← FDA DRUG APPROVALS

FDA NDA · NDA022015

MIRALAX

polyethylene glycol 3350

Sponsor: BAYER HEALTHCARE LLC

APPLICATION
NDA022015
TYPE
NDA
ORIGINAL APPROVAL
2006-10-06
LATEST ACTION
2025-02-03
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Over-the-counter

Products

MIRALAX · ReferenceOver-the-counter
POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL · FOR SOLUTION · ORAL
MIRALAX · ReferenceOver-the-counter
POLYETHYLENE GLYCOL 3350 17GM/PACKET · FOR SOLUTION · ORAL

Approval history

2025-02-03Labeling · Supplement 50 · standard — Letter ↗AP
2023-09-18Labeling · Supplement 48 · standard — Letter ↗AP
2023-07-27Labeling · Supplement 47 · standard — Letter ↗AP
2023-06-20Labeling · Supplement 46 · standard — Label ↗AP
2023-03-23Labeling · Supplement 45 · standard — Label ↗AP
2022-07-05Labeling · Supplement 43 · standard — Letter ↗AP
2021-04-27Labeling · Supplement 40 · standard — Letter ↗AP
2019-06-03Labeling · Supplement 35 · standard — Label ↗AP
2018-10-12Labeling · Supplement 34 · standard — Label ↗AP
2018-08-17Labeling · Supplement 33 · standard — Letter ↗AP
2018-05-04Labeling · Supplement 30 · standard — Letter ↗AP
2018-04-24Labeling · Supplement 29 · standard — Letter ↗AP
2017-10-04Labeling · Supplement 27 · standard — Letter ↗AP
2016-10-21Labeling · Supplement 26 · standard — Letter ↗AP
2016-09-30Labeling · Supplement 25 · standard — Letter ↗AP
2015-11-12Labeling · Supplement 24 · standard — Letter ↗AP
2015-10-29Labeling · Supplement 23 · standard — Label ↗AP
2015-09-24Manufacturing (CMC) · Supplement 18 · standardAP
2015-07-14Manufacturing (CMC) · Supplement 22 · standardAP
2014-08-03Manufacturing (CMC) · Supplement 20 · standard — Label ↗AP
2014-03-05Manufacturing (CMC) · Supplement 19 · standardAP
2013-10-22Manufacturing (CMC) · Supplement 17 · standardAP
2013-01-04Manufacturing (CMC) · Supplement 16 · standardAP
2012-03-15Labeling · Supplement 12 · standard — Letter ↗AP
2010-05-05Labeling · Supplement 6 · standard — Letter ↗AP
2008-12-02Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2008-11-20Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2006-10-06Type 8 - Partial Rx to OTC Switch · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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