Drugs@FDA: FDA-Approved Drugs
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 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 |
|---|---|---|---|---|---|---|---|
| 07/16/1986 | 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 |
|---|---|---|---|---|---|
| 08/13/2002 | SUPPL-39 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/09/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1996 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/2000 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/2000 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/31/2000 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1997 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 08/31/2000 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/19/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1992 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1992 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1992 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1992 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 01/06/1992 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/06/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/06/1992 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/11/1989 | SUPPL-16 | Bioequivalence |
Label is not available on this site. |
||
| 09/14/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/14/1990 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/02/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/17/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/15/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/12/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |