Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022304
Company: COLLEGIUM PHARM INC
Company: COLLEGIUM PHARM INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NUCYNTA | TAPENTADOL HYDROCHLORIDE | EQ 50MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| NUCYNTA | TAPENTADOL HYDROCHLORIDE | EQ 75MG BASE | TABLET;ORAL | Prescription | None | Yes | No |
| NUCYNTA | TAPENTADOL HYDROCHLORIDE | EQ 100MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 11/20/2008 | 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/2008/022304s000lbl_v2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022304s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022304s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022304Orig1s026ltr.pdf | |
| 07/03/2023 | SUPPL-24 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022304s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022304Orig1s024ltr.pdf | |
| 03/04/2021 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022304s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022304Orig1s023ltr.pdf | |
| 10/07/2019 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022304s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022304Orig1s022ltr.pdf | |
| 09/18/2018 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022304Orig1s019s021ltr.pdf | |
| 09/18/2018 | SUPPL-19 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022304Orig1s019s021ltr.pdf | |
| 12/16/2016 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022304Orig1s016ltr.pdf | |
| 10/31/2013 | SUPPL-15 | Labeling-Package Insert, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s014,s015ltr.pdf | |
| 10/31/2013 | SUPPL-14 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s014,s015ltr.pdf | |
| 01/16/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/2013 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf | |
| 07/11/2013 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf | |
| 07/11/2013 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf | |
| 07/11/2013 | SUPPL-8 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf | |
| 07/11/2013 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf | |
| 11/01/2010 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022304s003,s004ltr.pdf | |
| 11/01/2010 | SUPPL-3 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022304s003,s004ltr.pdf | |
| 11/09/2009 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022304s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022304s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022304s026lbl.pdf | |
| 07/03/2023 | SUPPL-24 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022304s024lbl.pdf | |
| 03/04/2021 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022304s023lbl.pdf | |
| 10/07/2019 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022304s022lbl.pdf | |
| 09/18/2018 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf | |
| 09/18/2018 | SUPPL-19 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf | |
| 12/16/2016 | SUPPL-16 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf | |
| 12/16/2016 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf | |
| 12/16/2016 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf | |
| 10/31/2013 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf | |
| 10/31/2013 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf | |
| 10/31/2013 | SUPPL-14 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf | |
| 07/11/2013 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf | |
| 07/11/2013 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf | |
| 07/11/2013 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf | |
| 07/11/2013 | SUPPL-8 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf | |
| 07/11/2013 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf | |
| 11/01/2010 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s004lbl.pdf | |
| 11/01/2010 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s004lbl.pdf | |
| 11/01/2010 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s003lbl.pdf | |
| 11/09/2009 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022304s001lbl.pdf | |
| 11/20/2008 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022304s000lbl_v2.pdf |