Drugs@FDA: FDA-Approved Drugs
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROXICET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG/5ML;5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 12/03/1986 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/14/2024 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-29 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2011 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2007 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 05/15/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/01/2001 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1997 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1997 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/16/1994 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/29/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/15/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 07/01/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/15/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |