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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208090
Company: COLLEGIUM PHARM INC

Medication Guide

REMS

FDA has determined that this product has abuse-deterrent properties

Products on NDA 208090

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XTAMPZA ER	OXYCODONE	9MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
XTAMPZA ER	OXYCODONE	13.5MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
XTAMPZA ER	OXYCODONE	18MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
XTAMPZA ER	OXYCODONE	27MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	No
XTAMPZA ER	OXYCODONE	36MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208090

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/26/2016	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208090s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208090Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208090Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208090s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208090Orig1s021ltr.pdf
03/04/2021	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208090s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208090Orig1s015ltr.pdf
10/07/2019	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208090s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208090Orig1s012ltr.pdf
09/18/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208090s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208090Orig1s008s010ltr.pdf
10/26/2018	SUPPL-9		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208090Orig1s009Ltr.pdf
09/18/2018	SUPPL-8	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208090s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208090Orig1s008s010ltr.pdf
05/26/2017	SUPPL-6	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208090Orig1s006ltr.pdf
11/06/2017	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208090s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208090Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208090Orig1s004.pdf
12/16/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208090s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208090Orig1s003ltr.pdf
09/30/2016	SUPPL-2	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208090Orig1s002ltr.pdf

Labels for NDA 208090

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208090s021lbl.pdf
03/04/2021	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208090s015lbl.pdf
10/07/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208090s012lbl.pdf
09/18/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208090s008s010lbl.pdf
09/18/2018	SUPPL-8	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208090s008s010lbl.pdf
11/06/2017	SUPPL-4	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208090s004lbl.pdf
12/16/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208090s003lbl.pdf
04/26/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208090s000lbl.pdf

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