Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 203794
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 20MG BASE/ML | SOLUTION;ORAL | Discontinued | None | Yes | No |
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.cfm 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 |
---|---|---|---|---|---|
12/15/2023 | 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. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
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 |