Drugs@FDA: FDA Approved Drug Products

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

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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