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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 203794
Company: COLLEGIUM PHARM INC

Medication Guide

REMS

Summary Review

Products on NDA 203794

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NUCYNTA	TAPENTADOL HYDROCHLORIDE	EQ 20MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 203794

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/15/2012	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203794Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203794_nucynta_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203794Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203794s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/203794Orig1s014ltr.pdf
06/14/2024	SUPPL-13	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203794s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203794Orig1s013ltr.pdf
10/31/2024	SUPPL-12	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203794Orig1s012ltr.pdf
12/15/2023	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203794s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203794Orig1s011ltr.pdf
07/03/2023	SUPPL-10	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203794Orig1s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203794Orig1s010ltr.pdf
03/04/2021	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203794s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/203794Orig1s009ltr.pdf
10/07/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203794s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203794Orig1s008ltr.pdf
09/18/2018	SUPPL-6	Labeling-Medication Guide	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203794Orig1s005s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf#page=34
09/18/2018	SUPPL-5	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203794Orig1s005s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf#page=34
12/16/2016	SUPPL-4	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203794s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203794Orig1s004ltr.pdf
11/17/2014	SUPPL-3	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003ltr.pdf
11/17/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003ltr.pdf
01/16/2014	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 203794

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-14	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203794s014lbl.pdf
12/22/2025	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/203794s014lbl.pdf
06/14/2024	SUPPL-13	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/203794s013lbl.pdf
12/15/2023	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203794s011lbl.pdf
12/15/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203794s011lbl.pdf
07/03/2023	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203794Orig1s010lbl.pdf
03/04/2021	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/203794s009lbl.pdf
10/07/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203794s008lbl.pdf
09/18/2018	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf
09/18/2018	SUPPL-5	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf
12/16/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203794s004lbl.pdf
12/16/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203794s004lbl.pdf
11/17/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf
11/17/2014	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf
11/17/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf
10/15/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000lbl.pdf

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