Drugs@FDA: FDA-Approved Drugs
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 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 |
|---|---|---|---|---|---|---|---|
| 08/09/1985 | 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 |
|---|---|---|---|---|---|
| 05/20/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/2000 | SUPPL-31 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/24/1996 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1995 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 06/05/1997 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1994 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1993 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/1993 | SUPPL-25 | Bioequivalence |
Label is not available on this site. |
||
| 12/02/1991 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1991 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |