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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011707
Company: ENDO PHARMS

Products on NDA 011707

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OPANA	OXYMORPHONE HYDROCHLORIDE	1.5MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No
OPANA	OXYMORPHONE HYDROCHLORIDE	1MG/ML	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011707

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/02/1959	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011707s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/011707Orig1s037ltr.pdf
12/16/2016	SUPPL-36	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011707s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/011707Orig1s036ltr.pdf
10/16/2006	SUPPL-31	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011707s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011707s031ltr.pdf
10/25/2002	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.
01/15/2002	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
04/16/2002	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
10/29/1997	SUPPL-26	Labeling		Label is not available on this site.
08/06/1997	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
09/25/2000	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
10/15/1996	SUPPL-23	Labeling		Label is not available on this site.
08/11/1994	SUPPL-22	Manufacturing (CMC)-Packaging		Label is not available on this site.
05/11/1994	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
12/08/1987	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
08/24/1993	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
08/31/1983	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/31/1983	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
11/09/1981	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
04/01/1981	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
03/26/1976	SUPPL-8	Labeling		Label is not available on this site.

Labels for NDA 011707

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/011707s037lbl.pdf
12/16/2016	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011707s036lbl.pdf
12/16/2016	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/011707s036lbl.pdf
10/16/2006	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011707s031lbl.pdf

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