Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 200533
Company: DEPO NF
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 150MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 200MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
NUCYNTA ER TAPENTADOL HYDROCHLORIDE EQ 250MG BASE TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/25/2011 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200533s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200533s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200533Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200533s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200533Orig1s020ltr.pdf
09/18/2018 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200533Orig1s018s019ltr.pdf
09/18/2018 SUPPL-18 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200533Orig1s018s019ltr.pdf
05/26/2017 SUPPL-16 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/200533Orig1s016ltr.pdf
09/30/2016 SUPPL-15 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s015ltr.pdf
12/16/2016 SUPPL-14 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s014ltr.pdf
04/20/2016 SUPPL-13 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200533Orig1s013ltr.pdf
06/26/2015 SUPPL-12 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200533Orig1s012ltr.pdf
08/19/2014 SUPPL-11 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200533Orig1s011ltr.pdf
04/16/2014 SUPPL-10 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200533s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200533Orig1s010ltr.pdf
01/16/2014 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/15/2013 SUPPL-4 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200533Orig1s004ltr.pdf
07/09/2012 SUPPL-2 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s002ltr.pdf
08/28/2012 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200533Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200533s020lbl.pdf
09/18/2018 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf
09/18/2018 SUPPL-18 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200533s018s019lbl.pdf
12/16/2016 SUPPL-14 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf
12/16/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf
12/16/2016 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200533s014lbl.pdf
04/16/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200533s010lbl.pdf
04/16/2014 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200533s010lbl.pdf
08/28/2012 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s001lbl.pdf
07/09/2012 SUPPL-2 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/200533s002lbl.pdf
08/25/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200533s000lbl.pdf

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