Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 201655
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-Medication Guide, Labeling-Package Insert 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-Package Insert, Labeling-Medication Guide 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-Modified, REMS-Assessment 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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201655s026lbl.pdf
10/07/2019 SUPPL-26 Labeling-Package Insert 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201655s012lbl.pdf
04/16/2014 SUPPL-12 Labeling-Medication Guide 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-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201655s002lbl.pdf
07/09/2012 SUPPL-2 REMS-Assessment 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

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