Application Sponsors
| ANDA 086162 | HIKMA INTL PHARMS | |
Marketing Status
Application Products
| 002 | TABLET;ORAL | 325MG;50MG;40MG | 0 | BUTALBITAL, ASPIRIN AND CAFFEINE | ASPIRIN; BUTALBITAL; CAFFEINE |
FDA Submissions
| ORIG | 1 | AP | 1979-06-05 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1982-10-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1984-02-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1988-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1988-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1988-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 1988-11-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1988-11-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1988-11-17 | |
| LABELING; Labeling | SUPPL | 24 | AP | 1988-11-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1988-11-17 | |
| LABELING; Labeling | SUPPL | 26 | AP | 1989-02-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1989-05-24 | |
| LABELING; Labeling | SUPPL | 28 | AP | 1989-05-24 | |
| BIOEQUIV; Bioequivalence | SUPPL | 29 | AP | 1989-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 1991-01-31 | |
| LABELING; Labeling | SUPPL | 32 | AP | 1992-06-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1996-10-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1996-02-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1996-08-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 1997-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 40 | AP | 1997-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 41 | AP | 1997-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 42 | AP | 1997-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 43 | AP | 1997-07-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 44 | AP | 1998-10-01 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 45 | AP | 1999-06-24 | |
Submissions Property Types
| SUPPL | 9 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
| SUPPL | 20 | Null | 0 |
| SUPPL | 21 | Null | 0 |
| SUPPL | 22 | Null | 0 |
| SUPPL | 23 | Null | 0 |
| SUPPL | 25 | Null | 0 |
| SUPPL | 27 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
| SUPPL | 40 | Null | 0 |
| SUPPL | 41 | Null | 0 |
| SUPPL | 42 | Null | 0 |
| SUPPL | 43 | Null | 0 |
| SUPPL | 44 | Null | 0 |
| SUPPL | 45 | Null | 0 |
TE Codes
CDER Filings
HIKMA INTL PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 86162
[companyName] => HIKMA INTL PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"BUTALBITAL, ASPIRIN AND CAFFEINE","activeIngredients":"ASPIRIN; BUTALBITAL; CAFFEINE","strength":"325MG;50MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"BUTALBITAL, ASPIRIN AND CAFFEINE","submission":"ASPIRIN; BUTALBITAL; CAFFEINE","actionType":"325MG;50MG;40MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)