Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 203794
Company: ASSERTIO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUCYNTA TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML SOLUTION;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
10/15/2012 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/203794Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203794_nucynta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/203794Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-6 Labeling-Medication Guide Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203794Orig1s005s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf#page=34
09/18/2018 SUPPL-5 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203794Orig1s005s006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf#page=34
12/16/2016 SUPPL-4 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203794s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203794Orig1s004ltr.pdf
11/17/2014 SUPPL-3 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003ltr.pdf
11/17/2014 SUPPL-2 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203794Orig1s002,s003ltr.pdf
01/16/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2018 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf
09/18/2018 SUPPL-5 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203794s005s006lbl.pdf
12/16/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203794s004lbl.pdf
12/16/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203794s004lbl.pdf
11/17/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf
11/17/2014 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf
11/17/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203794s002s003lbl.pdf
10/15/2012 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203794s000lbl.pdf

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