Application Sponsors
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | 500MG;5MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1985-07-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1989-11-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1989-04-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1989-04-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1989-04-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1989-11-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1989-11-03 | |
| LABELING; Labeling | SUPPL | 10 | AP | 1989-11-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1989-11-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1991-07-11 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1990-06-04 | |
| LABELING; Labeling | SUPPL | 24 | AP | 1991-09-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1991-12-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1993-12-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1994-09-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1997-06-05 | |
| LABELING; Labeling | SUPPL | 30 | AP | 1996-04-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2000-07-20 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 11 | 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 | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 32 | Null | 0 |
CDER Filings
MALLINCKRODT
cder:Array
(
[0] => Array
(
[ApplNo] => 88956
[companyName] => MALLINCKRODT
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)