Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021610
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OPANA ER OXYMORPHONE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OPANA ER OXYMORPHONE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OPANA ER OXYMORPHONE HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OPANA ER OXYMORPHONE HYDROCHLORIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OPANA ER OXYMORPHONE HYDROCHLORIDE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OPANA ER OXYMORPHONE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
OPANA ER OXYMORPHONE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, EXTENDED RELEASE;ORAL Discontinued None No No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
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
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
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

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