Drugs@FDA: FDA-Approved Drugs
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | AA | 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 |
|---|---|---|---|---|---|---|---|
| 01/21/1987 | 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 |
|---|---|---|---|---|---|
| 10/18/2013 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2011 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2009 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 11/20/2002 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 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. |
||
| 01/15/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1997 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/16/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1996 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1996 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 11/17/1993 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 11/17/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 07/14/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/14/1989 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/02/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/02/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/20/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
TABLET;ORAL; 325MG;50MG;40MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 211106 | ABHAI LLC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | Yes | AA | 088616 | ACTAVIS LABS UT INC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 040864 | GRANULES |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 200243 | LANNETT CO INC |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 209587 | LGM PHARMA |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 089175 | MIKART |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 214287 | QUAGEN |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 040511 | STRIDES PHARMA |
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;ORAL | Prescription | No | AA | 203647 | STRIDES PHARMA |