Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089775
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROXICET 5/500 | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;5MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 01/12/1989 | 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 |
|---|---|---|---|---|---|
| 06/01/2001 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/13/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/25/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/15/1989 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |