Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022015
Company: BAYER HEALTHCARE LLC
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 |
|---|---|---|---|---|---|
| 09/18/2023 | SUPPL-48 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022015Orig1s048Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022015Orig1s048Correctedltr.pdf | |
| 07/27/2023 | SUPPL-47 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022015Orig1s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022015Orig1s047ltr.pdf | |
| 06/20/2023 | SUPPL-46 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022015Orig1s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022015Orig1s046ltr.pdf | |
| 03/23/2023 | SUPPL-45 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022015Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022015orig1s045ltr.pdf | |
| 07/05/2022 | SUPPL-43 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022015Orig1s043Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022015Orig1s043Correctedltr.pdf | |
| 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-Package Insert, Labeling-Container/Carton Labels |
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 |
|---|---|---|---|---|---|
| 09/18/2023 | SUPPL-48 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022015Orig1s048Correctedlbl.pdf | |
| 07/27/2023 | SUPPL-47 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022015Orig1s047lbl.pdf | |
| 06/20/2023 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022015Orig1s046lbl.pdf | |
| 06/20/2023 | SUPPL-46 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022015Orig1s046lbl.pdf | |
| 03/23/2023 | SUPPL-45 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022015Orig1s045lbl.pdf | |
| 07/05/2022 | SUPPL-43 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022015Orig1s043Correctedlbl.pdf | |
| 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 |
|---|---|---|---|---|---|---|---|
| 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 | 202071 | ELYSIUM |
| 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 | 206105 | NUVO PHARMS INC |
| 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 | 079214 | STRIDES PHARMA |
| POLYETHYLENE GLYCOL 3350 | POLYETHYLENE GLYCOL 3350 | 17GM/SCOOPFUL | FOR SOLUTION;ORAL | Over-the-counter | No | 203928 | STRIDES PHARMA |