Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040061
Company: ROXANE
Company: ROXANE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ROXILOX | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;5MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 07/03/1995 | 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 |
|---|---|---|---|---|---|
| 08/14/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 04/26/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/26/2001 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 04/22/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/19/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/19/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |