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OXYCODONE HYDROCHLORIDE | 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 02/25/1980 | 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 |
|---|---|---|---|---|---|
| 12/22/2025 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-48 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 03/07/2024 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-41 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-38 | Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/12/2014 | SUPPL-36 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2011 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2007 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 06/05/2001 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 03/22/1999 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/23/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/13/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/15/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/29/1991 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/29/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/01/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/01/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/01/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1982 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/01/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |