Drugs@FDA: FDA-Approved Drugs
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESGIC-PLUS | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 500MG;50MG;40MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/23/1988 | 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-34 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/28/2001 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1998 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1997 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/20/1996 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/16/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 02/25/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 02/25/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1993 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/25/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/25/1993 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/13/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/13/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/13/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/12/1989 | SUPPL-5 | Bioequivalence |
Label is not available on this site. |
||
| 03/27/1990 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/29/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |