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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200533
Company: COLLEGIUM PHARM INC

Medication Guide

REMS

Products on NDA 200533

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 50MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 100MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 200MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
NUCYNTA ER	TAPENTADOL HYDROCHLORIDE	EQ 250MG BASE	TABLET, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200533

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2011	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200533s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200533s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200533Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/14/2024	SUPPL-29	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200533s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/200533Orig1s029ltr.pdf
12/15/2023	SUPPL-27	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200533s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/200533Orig1s027ltr.pdf
03/04/2021	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200533s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200533Orig1s023ltr.pdf
10/07/2019	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200533s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200533Orig1s020ltr.pdf
09/18/2018	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200533Orig1s018s019ltr.pdf
09/18/2018	SUPPL-18	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200533Orig1s018s019ltr.pdf
05/26/2017	SUPPL-16	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200533Orig1s016ltr.pdf
09/30/2016	SUPPL-15	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s015ltr.pdf
12/16/2016	SUPPL-14	Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s014ltr.pdf
04/20/2016	SUPPL-13	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s013ltr.pdf
06/26/2015	SUPPL-12	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200533Orig1s012ltr.pdf
08/19/2014	SUPPL-11	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200533Orig1s011ltr.pdf
04/16/2014	SUPPL-10	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200533s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200533Orig1s010ltr.pdf
01/16/2014	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
04/15/2013	SUPPL-4	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200533Orig1s004ltr.pdf
07/09/2012	SUPPL-2	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s002ltr.pdf
08/28/2012	SUPPL-1	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s001ltr.pdf

Labels for NDA 200533

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/14/2024	SUPPL-29	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200533s029lbl.pdf
12/15/2023	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200533s027lbl.pdf
12/15/2023	SUPPL-27	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200533s027lbl.pdf
03/04/2021	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200533s023lbl.pdf
10/07/2019	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200533s020lbl.pdf
09/18/2018	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf
09/18/2018	SUPPL-18	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf
12/16/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf
12/16/2016	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf
12/16/2016	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf
04/16/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200533s010lbl.pdf
04/16/2014	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200533s010lbl.pdf
08/28/2012	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s001lbl.pdf
07/09/2012	SUPPL-2	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s002lbl.pdf
08/25/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200533s000lbl.pdf

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