Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 650MG;7.5MG | 0 | ANEXSIA 7.5/650 | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1987-09-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-08-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1988-08-10 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1989-08-23 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1990-06-29 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1990-06-29 | |
| LABELING; Labeling | SUPPL | 7 | AP | 1991-05-03 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1995-04-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1995-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1995-05-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1995-06-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1995-06-26 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1997-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2000-04-07 | |
| LABELING; Labeling | SUPPL | 21 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 2000-04-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2002-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 2002-09-19 | |
| LABELING; Labeling | SUPPL | 29 | AP | 2002-09-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2002-09-27 | |
| LABELING; Labeling | SUPPL | 31 | AP | 2002-11-13 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 5 | 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 | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | 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 | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
CDER Filings
MALLINCKRODT
cder:Array
(
[0] => Array
(
[ApplNo] => 89725
[companyName] => MALLINCKRODT
[docInserts] => ["",""]
[products] => [{"drugName":"ANEXSIA 7.5\/650","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"650MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"ANEXSIA 7.5\/650","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"650MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)