Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022304
Company: DEPO NF
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NUCYNTA TAPENTADOL HYDROCHLORIDE EQ 50MG BASE TABLET;ORAL Prescription None Yes No
NUCYNTA TAPENTADOL HYDROCHLORIDE EQ 75MG BASE TABLET;ORAL Prescription None Yes No
NUCYNTA TAPENTADOL HYDROCHLORIDE EQ 100MG BASE TABLET;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
11/20/2008 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022304s000lbl_v2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022304s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022304Orig1s019s021ltr.pdf
09/18/2018 SUPPL-19 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022304Orig1s019s021ltr.pdf
12/16/2016 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022304Orig1s016ltr.pdf
10/31/2013 SUPPL-15 Labeling, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s014,s015ltr.pdf
10/31/2013 SUPPL-14 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s014,s015ltr.pdf
01/16/2014 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/11/2013 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf
07/11/2013 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf
07/11/2013 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf
07/11/2013 SUPPL-8 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf
07/11/2013 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022304Orig1s007,s008,s009,s011,s012ltr.pdf
11/01/2010 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022304s003,s004ltr.pdf
11/01/2010 SUPPL-3 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022304s003,s004ltr.pdf
11/09/2009 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022304s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022304s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2018 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf
09/18/2018 SUPPL-19 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022304s019s021lbl.pdf
12/16/2016 SUPPL-16 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf
12/16/2016 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022304s016lbl.pdf
10/31/2013 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf
10/31/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf
10/31/2013 SUPPL-14 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s014s015lbl.pdf
07/11/2013 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf
07/11/2013 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf
07/11/2013 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf
07/11/2013 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf
07/11/2013 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022304s007s008s009s011s012lbl.pdf
11/01/2010 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s004lbl.pdf
11/01/2010 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s004lbl.pdf
11/01/2010 SUPPL-3 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022304s003lbl.pdf
11/09/2009 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022304s001lbl.pdf
11/20/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022304s000lbl_v2.pdf

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