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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021611
Company: ENDO PHARMS

Medication Guide

REMS

Products on NDA 021611

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OPANA	OXYMORPHONE HYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
OPANA	OXYMORPHONE HYDROCHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021611

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2006	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021611lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021611s000LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021610s000_021611s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-17	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021611Orig1s017ltr.pdf
10/25/2019	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021611Orig1s016ltr.pdf
09/18/2018	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021611s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021611Orig1s013s015ltr.pdf
09/18/2018	SUPPL-13	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021611s013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021611Orig1s013s015ltr.pdf
12/22/2016	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/16/2016	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021611Orig1s010ltr.pdf
09/17/2013	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
07/09/2012	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021611s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021611Orig1s007ltr.pdf
02/03/2011	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021611s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021611s005ltr.pdf
04/15/2010	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021611s004ltr.pdf
08/02/2006	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021610s001, 021611s001LTR.pdf

Labels for NDA 021611

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/25/2019	SUPPL-16	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s016lbl.pdf
10/07/2019	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s017lbl.pdf
10/07/2019	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s017lbl.pdf
09/18/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021611s013s015lbl.pdf
09/18/2018	SUPPL-13	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021611s013s015lbl.pdf
12/16/2016	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf
12/16/2016	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021611s010lbl.pdf
07/09/2012	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021611s007lbl.pdf
02/03/2011	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021611s005lbl.pdf
08/02/2006	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021610s001,021611s001lbl.pdf
06/22/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021611lbl.pdf

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