Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011707
Company: ENDO PHARMS
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 |
| 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 |