Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201655
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 | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 7.5MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 15MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 20MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 30MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | Yes | No |
| OPANA ER | OXYMORPHONE HYDROCHLORIDE | 40MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/09/2011 | 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/2011/201655lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201655Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201655_opana_er_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201655Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-26 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201655s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201655Orig1s026ltr.pdf | |
| 09/18/2018 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201655s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201655Orig1s024s025ltr.pdf | |
| 09/18/2018 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201655s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201655Orig1s024s025ltr.pdf | |
| 05/26/2017 | SUPPL-23 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201655Orig1s023ltr.pdf |
| 09/30/2016 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201655Orig1s022ltr.pdf |
| 12/16/2016 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201655s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201655Orig1s021ltr.pdf | |
| 04/20/2016 | SUPPL-20 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201655Orig1s020ltr.pdf |
| 02/22/2016 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/24/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-17 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201655Orig1s017ltr.pdf |
| 01/28/2015 | SUPPL-16 | REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201655s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201655Orig1s016ltr.pdf | |
| 08/19/2014 | SUPPL-15 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201655Orig1s015ltr.pdf |
| 09/23/2014 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/2014 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201655s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201655Orig1s012ltr.pdf | |
| 12/05/2013 | SUPPL-10 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/29/2013 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/2013 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/2013 | SUPPL-5 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201655Orig1s005ltr.pdf |
| 01/14/2013 | SUPPL-4 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201655s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/201655Orig1s004ltr.pdf | |
| 07/09/2012 | SUPPL-2 | REMS-Assessment, REMS-Modified |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201655s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201655Orig1s002ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/07/2019 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201655s026lbl.pdf | |
| 10/07/2019 | SUPPL-26 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201655s026lbl.pdf | |
| 09/18/2018 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201655s024s025lbl.pdf | |
| 09/18/2018 | SUPPL-24 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201655s024s025lbl.pdf | |
| 12/16/2016 | SUPPL-21 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201655s021lbl.pdf | |
| 12/16/2016 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201655s021lbl.pdf | |
| 01/28/2015 | SUPPL-16 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/201655s016lbl.pdf | |
| 04/16/2014 | SUPPL-12 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201655s012lbl.pdf | |
| 04/16/2014 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201655s012lbl.pdf | |
| 01/14/2013 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/201655s004lbl.pdf | |
| 07/09/2012 | SUPPL-2 | REMS-Assessment | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201655s002lbl.pdf | |
| 07/09/2012 | SUPPL-2 | REMS-Modified | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201655s002lbl.pdf | |
| 12/09/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201655lbl.pdf |