Drugs@FDA: FDA-Approved Drugs
Company: ACTAVIS LABS UT INC
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 | Yes | 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 |
---|---|---|---|---|---|---|---|
11/09/1984 | 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 |
---|---|---|---|---|---|
12/10/2014 | SUPPL-64 | Labeling-Package Insert |
Label is not available on this site. |
||
06/23/2011 | SUPPL-62 | Labeling-Package Insert |
Label is not available on this site. |
||
03/06/2002 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/15/2001 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/30/2001 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/18/2002 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
07/26/1999 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/1999 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/1999 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/01/1999 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/16/1998 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
11/20/1996 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
04/23/1996 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/20/1998 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
08/04/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/16/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/27/1993 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
08/20/1993 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
04/16/1992 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
01/30/1992 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
12/17/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
05/26/1992 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/1991 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/05/1991 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
09/11/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
08/24/1990 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
05/10/1990 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
03/21/1990 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/21/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/05/1991 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
05/15/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
03/21/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/21/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/18/1988 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/19/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/19/1986 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/19/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/19/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/19/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/19/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/30/1985 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/19/1985 | 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 |