Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021611
Company: ENDO PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OPANA OXYMORPHONE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB Yes No
OPANA OXYMORPHONE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB Yes Yes
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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021611s017lbl.pdf
10/07/2019 SUPPL-17 Labeling-Package Insert 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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English