Drugs@FDA: FDA-Approved Drugs
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANEXSIA 7.5/650 | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 650MG;7.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/30/1987 | 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 |
|---|---|---|---|---|---|
| 11/13/2002 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 09/27/2002 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/19/2002 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 09/19/2002 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/11/2002 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/07/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/11/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/26/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/03/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/29/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/23/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 08/10/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |