Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022272
Company: PURDUE PHARMA LP
Company: PURDUE PHARMA LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCONTIN | OXYCODONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| OXYCONTIN | OXYCODONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| OXYCONTIN | OXYCODONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| OXYCONTIN | OXYCODONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| OXYCONTIN | OXYCODONE HYDROCHLORIDE | 40MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | Yes |
| OXYCONTIN | OXYCODONE HYDROCHLORIDE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | None | Yes | No |
| OXYCONTIN | OXYCODONE HYDROCHLORIDE | 80MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 04/05/2010 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | PRIORITY |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022272s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2024 | SUPPL-49 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022272Orig1s049ltr.pdf |
| 12/15/2023 | SUPPL-48 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022272s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022272Orig1s048ltr.pdf | |
| 10/28/2021 | SUPPL-47 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022272Orig1s047ltr.pdf | |
| 03/04/2021 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022272Orig1s046ltr.pdf | |
| 10/07/2019 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022272s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022272Orig1s043ltr.pdf | |
| 11/14/2019 | SUPPL-42 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022272Orig1s042ltr.pdf |
| 09/18/2018 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022272Orig1s040s041ltr.pdf | |
| 09/18/2018 | SUPPL-40 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022272Orig1s040s041ltr.pdf | |
| 09/26/2018 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022272Orig1s039ltr.pdf | |
| 05/26/2017 | SUPPL-37 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022272Orig1s037ltr.pdf |
| 09/30/2016 | SUPPL-36 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022272Orig1s036ltr.pdf |
| 12/16/2016 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022272s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022272Orig1s034ltr.pdf | |
| 04/20/2016 | SUPPL-33 | REMS-Modified |
Label is not available on this site. |
||
| 03/28/2016 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/2015 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/10/2015 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-28 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s028ltr.pdf |
| 08/13/2015 | SUPPL-27 | Efficacy-Pediatric |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022272Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/022272Orig1s027TOC.cfm | |
| 10/13/2014 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/19/2014 | SUPPL-24 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022272Orig1s024ltr.pdf |
| 10/22/2014 | SUPPL-23 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019516Orig1s043,022272Orig1s023ltr.pdf | |
| 04/16/2014 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022272Orig1s022ltr.pdf | |
| 01/31/2014 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-17 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s017ltr.pdf |
| 01/11/2013 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020553Orig1s065,022272Orig1s016ltr.pdf | |
| 02/04/2014 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2013 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022272Orig1s014Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022272Orig1s014TOC.cfm | |
| 07/09/2012 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022272Orig1s011ltr.pdf | |
| 07/09/2012 | SUPPL-10 | REMS-Modified, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022272Orig1s010ltr.pdf | |
| 10/05/2011 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022272s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022272s009ltr.pdf | |
| 11/15/2010 | SUPPL-6 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s006ltr.pdf | |
| 06/29/2010 | SUPPL-5 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022272s005ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-48 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022272s048lbl.pdf | |
| 10/28/2021 | SUPPL-47 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s047lbl.pdf | |
| 03/04/2021 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s046lbl.pdf | |
| 10/07/2019 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022272s043lbl.pdf | |
| 09/26/2018 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s039lbl.pdf | |
| 09/18/2018 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf | |
| 09/18/2018 | SUPPL-40 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf | |
| 12/16/2016 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022272s034lbl.pdf | |
| 08/13/2015 | SUPPL-27 | Efficacy-Pediatric | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf | |
| 10/22/2014 | SUPPL-23 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272Orig1s023lbl.pdf | |
| 04/16/2014 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272s022lbl.pdf | |
| 04/16/2013 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272Orig1s014lbl.pdf | |
| 01/11/2013 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272s016lbl.pdf | |
| 07/09/2012 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s011lbl.pdf | |
| 07/09/2012 | SUPPL-10 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf | |
| 07/09/2012 | SUPPL-10 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf | |
| 10/05/2011 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022272s009lbl.pdf | |
| 11/15/2010 | SUPPL-6 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s006lbl.pdf | |
| 06/29/2010 | SUPPL-5 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s005lbl.pdf | |
| 04/05/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272lbl.pdf |