Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 204760
Company: VALINOR
Company: VALINOR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MOVANTIK | NALOXEGOL OXALATE | EQ 12.5MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
MOVANTIK | NALOXEGOL OXALATE | EQ 25MG BASE | TABLET;ORAL | Prescription | 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 |
---|---|---|---|---|---|---|---|
09/16/2014 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204760s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204760Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204760Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204760Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/13/2020 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204760s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204760Orig1s009ltr.pdf | |
05/29/2019 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204760s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204760Orig1s008ltr.pdf | |
02/28/2018 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204760Orig1s007ltr.pdf | |
08/01/2017 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204760s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204760Orig1s005ltr.pdf | |
08/22/2016 | SUPPL-3 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s002,s003ltr.pdf | |
08/22/2016 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s002,s003ltr.pdf | |
07/22/2016 | SUPPL-1 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204760Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/13/2020 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204760s009lbl.pdf | |
05/29/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204760s008lbl.pdf | |
02/28/2018 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf | |
02/28/2018 | SUPPL-7 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf | |
08/01/2017 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204760s005lbl.pdf | |
08/01/2017 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204760s005lbl.pdf | |
08/22/2016 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf | |
08/22/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s002s003lbl.pdf | |
07/22/2016 | SUPPL-1 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204760s001lbl.pdf | |
09/16/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204760s000lbl.pdf |