Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 325MG;50MG;40MG | 0 | BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
FDA Submissions
| ORIG | 1 | AP | 1987-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-05-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1988-05-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1988-05-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1988-05-20 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1988-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1991-08-02 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1991-08-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1988-12-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1989-06-02 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1989-07-14 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1989-07-14 | |
| LABELING; Labeling | SUPPL | 13 | AP | 1992-01-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1993-11-17 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1993-11-17 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1993-11-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1995-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1996-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1996-03-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1995-08-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1995-10-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1995-10-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1997-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1997-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1997-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1997-06-27 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1997-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1997-01-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1997-01-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1998-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 1998-06-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2001-03-28 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 2002-08-13 | |
| LABELING; Labeling | SUPPL | 35 | AP | 2002-11-20 | |
| LABELING; Labeling | SUPPL | 42 | AP | 2009-06-22 | |
| LABELING; Labeling | SUPPL | 44 | AP | 2011-06-22 | |
| LABELING; Labeling | SUPPL | 45 | AP | 2013-10-18 | STANDARD |
Submissions Property Types
| SUPPL | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 19 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 24 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 26 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 44 | Null | 7 |
| SUPPL | 45 | Null | 7 |
TE Codes
CDER Filings
MIKART
cder:Array
(
[0] => Array
(
[ApplNo] => 89175
[companyName] => MIKART
[docInserts] => ["",""]
[products] => [{"drugName":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","activeIngredients":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","strength":"325MG;50MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BUTALBITAL, ACETAMINOPHEN AND CAFFEINE","submission":"ACETAMINOPHEN; BUTALBITAL; CAFFEINE","actionType":"325MG;50MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)