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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204760
Company: VALINOR

Medication Guide

Summary Review

Products on NDA 204760

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204760

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-Medication Guide, Labeling-Package Insert	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-Medication Guide, Labeling-Package Insert	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

Labels for NDA 204760

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-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf
02/28/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204760s007lbl.pdf
08/01/2017	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204760s005lbl.pdf
08/01/2017	SUPPL-5	Labeling-Package Insert	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

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