Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 208090
Company: COLLEGIUM PHARM INC
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
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
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)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208090s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208090Orig1s004ltr.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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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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