Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021610
Company: ENDO PHARMS
Company: ENDO PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 06/22/2006 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021610s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021610Orig1s031ltr.pdf | |
| 04/28/2022 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021610s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021610s030ltr.pdf | |
| 03/04/2021 | SUPPL-28 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021610s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021610Orig1s028ltr.pdf | |
| 10/07/2019 | SUPPL-27 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021610s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021610Orig1s027ltr.pdf | |
| 09/18/2018 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021610s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021610Orig1s025s026ltr.pdf | |
| 09/18/2018 | SUPPL-25 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021610s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021610Orig1s025s026ltr.pdf | |
| 05/26/2017 | SUPPL-24 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021610Orig1s024ltr.pdf |
| 09/30/2016 | SUPPL-23 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021610Orig1s023ltr.pdf |
| 12/16/2016 | SUPPL-22 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021610s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021610Orig1s022ltr.pdf | |
| 04/20/2016 | SUPPL-21 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021610Orig1s021ltr.pdf |
| 06/26/2015 | SUPPL-20 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021610Orig1s020ltr.pdf |
| 08/19/2014 | SUPPL-19 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021610Orig1s019ltr.pdf |
| 04/16/2014 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021610s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021610Orig1s018ltr.pdf | |
| 02/23/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-14 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021610Orig1s014ltr.pdf |
| 07/09/2012 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021610Orig1s013ltr.pdf | |
| 07/09/2012 | SUPPL-12 | REMS-Proposal |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021610Orig1s012ltr.pdf | |
| 10/04/2010 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021610s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021610s009ltr.pdf | |
| 02/29/2008 | SUPPL-6 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021610s006ltr.pdf | |
| 01/10/2008 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021610s005ltr.pdf | |
| 07/09/2007 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021610s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021610s003ltr.pdf | |
| 08/02/2006 | SUPPL-1 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021610s001, 021611s001LTR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-31 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021610s031lbl.pdf | |
| 12/15/2023 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021610s031lbl.pdf | |
| 04/28/2022 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021610s030lbl.pdf | |
| 03/04/2021 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021610s028lbl.pdf | |
| 03/04/2021 | SUPPL-28 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021610s028lbl.pdf | |
| 10/07/2019 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021610s027lbl.pdf | |
| 10/07/2019 | SUPPL-27 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021610s027lbl.pdf | |
| 09/18/2018 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021610s025s026lbl.pdf | |
| 09/18/2018 | SUPPL-25 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021610s025s026lbl.pdf | |
| 12/16/2016 | SUPPL-22 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021610s022lbl.pdf | |
| 12/16/2016 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021610s022lbl.pdf | |
| 04/16/2014 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021610s018lbl.pdf | |
| 04/16/2014 | SUPPL-18 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021610s018lbl.pdf | |
| 07/09/2012 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s013lbl.pdf | |
| 07/09/2012 | SUPPL-12 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021610s012lbl.pdf | |
| 10/04/2010 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021610s009lbl.pdf | |
| 02/29/2008 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s006lbl.pdf | |
| 02/29/2008 | SUPPL-6 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s006lbl.pdf | |
| 01/10/2008 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s005lbl.pdf | |
| 01/10/2008 | SUPPL-5 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021610s005lbl.pdf | |
| 07/09/2007 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021610s003lbl.pdf | |
| 08/02/2006 | SUPPL-1 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf |