Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205777
Company: PURDUE PHARMA LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TARGINIQ NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE 5MG;10MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
TARGINIQ NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE 10MG;20MG TABLET, EXTENDED RELEASE;ORAL Discontinued None Yes No
TARGINIQ NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE 20MG;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
07/23/2014 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205777lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205777Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205777Orig1s010s011ltr.pdf
09/18/2018 SUPPL-10 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205777Orig1s010s011ltr.pdf
05/26/2017 SUPPL-7 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205777Orig1s007ltr.pdf
09/30/2016 SUPPL-5 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s005ltr.pdf
12/16/2016 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205777s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s004ltr.pdf
04/20/2016 SUPPL-3 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205777Orig1s003ltr.pdf
06/26/2015 SUPPL-2 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205777Orig1s002ltr.pdf
08/19/2014 SUPPL-1 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205777Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/18/2018 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf
09/18/2018 SUPPL-10 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205777s010s011lbl.pdf
12/16/2016 SUPPL-4 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205777s004lbl.pdf
12/16/2016 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205777s004lbl.pdf
07/23/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205777lbl.pdf

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