Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG;5MG | 0 | ANEXSIA | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1987-04-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1988-09-30 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1991-06-21 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1995-04-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-05-12 | |
| LABELING; Labeling | SUPPL | 12 | AP | 1997-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-07-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2000-03-15 | |
| LABELING; Labeling | SUPPL | 24 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2000-03-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2002-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2002-09-19 | |
| LABELING; Labeling | SUPPL | 34 | AP | 2002-09-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 2002-07-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 2002-11-05 | |
| LABELING; Labeling | SUPPL | 37 | AP | 2002-11-13 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 10 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 17 | 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 | 28 | 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 | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
CDER Filings
MALLINCKRODT
cder:Array
(
[0] => Array
(
[ApplNo] => 89160
[companyName] => MALLINCKRODT
[docInserts] => ["",""]
[products] => [{"drugName":"ANEXSIA","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ANEXSIA","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)