Drugs@FDA: FDA-Approved Drugs
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. |
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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. |
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08/06/1997 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/25/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/15/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
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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. |
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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. |
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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 |