Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 209777
Company: PROTEGA PHARMS
Company: PROTEGA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ROXYBOND | OXYCODONE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | None | No | No |
ROXYBOND | OXYCODONE HYDROCHLORIDE | 15MG | TABLET;ORAL | Prescription | None | No | No |
ROXYBOND | OXYCODONE HYDROCHLORIDE | 30MG | TABLET;ORAL | Prescription | None | No | No |
ROXYBOND | OXYCODONE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | None | No | 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 |
---|---|---|---|---|---|---|---|
04/20/2017 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209777Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209777Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/31/2024 | SUPPL-10 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
04/19/2024 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209777s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209777Orig1s009ltr.pdf | |
12/15/2023 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209777s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209777Orig1s008ltr.pdf | |
03/04/2021 | SUPPL-7 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209777s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209777Orig1s007ltr.pdf | |
10/07/2019 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209777s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209777Orig1s006ltr.pdf | |
09/18/2018 | SUPPL-3 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209777Orig1s001s003ltr.pdf | |
12/31/2018 | SUPPL-2 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209777Orig1s002ltr.pdf | |
09/18/2018 | SUPPL-1 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209777Orig1s001s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/19/2024 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209777s009lbl.pdf | |
04/19/2024 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209777s009lbl.pdf | |
12/15/2023 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209777s008lbl.pdf | |
03/04/2021 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209777s007lbl.pdf | |
10/07/2019 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209777s006lbl.pdf | |
12/31/2018 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s002lbl.pdf | |
09/18/2018 | SUPPL-3 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf | |
09/18/2018 | SUPPL-3 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf | |
09/18/2018 | SUPPL-1 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209777s001s003lbl.pdf | |
04/20/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209777lbl.pdf |