Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 022015
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRALAX POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/06/2006 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022015s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/27/2021 SUPPL-40 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022015Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022015Orig1s040ltr.pdf
06/03/2019 SUPPL-35 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022015Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022015Orig1s035ltr.pdf
10/12/2018 SUPPL-34 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s034Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022015Orig1s034Ltr.pdf
08/17/2018 SUPPL-33 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s0333Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022015Orig1s0333Ltr.pdf
05/04/2018 SUPPL-30 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022015Orig1s030ltr.pdf
04/24/2018 SUPPL-29 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022015Orig1s029ltr.pdf
10/04/2017 SUPPL-27 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022015Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022015Orig1s027ltr.pdf
10/21/2016 SUPPL-26 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022015Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022015Orig1s026ltr.pdf
09/30/2016 SUPPL-25 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022015Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022015Orig1s025ltr.pdf
11/12/2015 SUPPL-24 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022015Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022015Orig1s024ltr.pdf
10/29/2015 SUPPL-23 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022015Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022015Orig1s023ltr.pdf
07/14/2015 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/03/2014 SUPPL-20 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022015Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022015Orig1s020ltr.pdf
03/05/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

09/24/2015 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/22/2013 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/04/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/15/2012 SUPPL-12 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022015Orig1s012ltr.pdf
05/05/2010 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022015s006ltr.pdf
12/02/2008 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022015s003ltr.pdf
11/20/2008 SUPPL-2 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022015s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/27/2021 SUPPL-40 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022015Orig1s040lbl.pdf
06/03/2019 SUPPL-35 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022015Orig1s035lbl.pdf
10/12/2018 SUPPL-34 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s034Lbl.pdf
08/17/2018 SUPPL-33 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s0333Lbl.pdf
05/04/2018 SUPPL-30 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s030lbl.pdf
04/24/2018 SUPPL-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022015Orig1s029lbl.pdf
10/04/2017 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022015Orig1s027lbl.pdf
10/21/2016 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022015Orig1s026lbl.pdf
09/30/2016 SUPPL-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022015Orig1s025lbl.pdf
11/12/2015 SUPPL-24 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022015Orig1s024lbl.pdf
10/29/2015 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022015Orig1s023lbl.pdf
08/03/2014 SUPPL-20 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022015Orig1s020lbl.pdf

MIRALAX

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

FOR SOLUTION;ORAL; 17GM/SCOOPFUL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
GLYCOLAX POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 090600 LANNETT CO INC
MIRALAX POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter Yes 022015 BAYER HEALTHCARE LLC
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 202850 ANI PHARMS
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 214990 ANNORA PHARMA
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 209017 AUROBINDO PHARMA LTD
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 090812 LGM PHARMA
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 078915 MYLAN
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 091077 NOVEL LABS INC
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 202071 NOVELGENIX THERAPS
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 206105 NUVO PHARMS INC
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 079214 PAR PHARM
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 090685 PERRIGO R AND D
POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION;ORAL Over-the-counter No 203928 STRIDES PHARMA

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English