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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 205777
Company: PURDUE PHARMA LP

Medication Guide

REMS

FDA has determined that this product has abuse-deterrent properties

Products on NDA 205777

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 205777

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

Labels for NDA 205777

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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