Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 003 |
| Discontinued | 004 |
Application Products
| 001 | TABLET;ORAL | 750MG;7.5MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| 002 | TABLET;ORAL | 500MG;5MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| 003 | TABLET;ORAL | 660MG;10MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
| 004 | TABLET;ORAL | 650MG;10MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1995-06-01 | |
| LABELING; Labeling | SUPPL | 2 | AP | 1996-07-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1996-07-03 | |
| LABELING; Labeling | SUPPL | 4 | AP | 1996-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1996-07-03 | |
| LABELING; Labeling | SUPPL | 6 | AP | 1996-07-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1996-10-16 | |
| LABELING; Labeling | SUPPL | 8 | AP | 1996-10-16 | |
| LABELING; Labeling | SUPPL | 9 | AP | 1997-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-03-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2000-03-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-03-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-03-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-03-13 | |
| LABELING; Labeling | SUPPL | 15 | AP | 2000-03-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2002-04-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 2002-12-02 | |
| LABELING; Labeling | SUPPL | 18 | AP | 2002-12-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2002-09-27 | |
| S; Supplement | SUPPL | 20 | AP | 2003-04-10 | |
| S; Supplement | SUPPL | 21 | AP | 2003-04-25 | |
| S; Supplement | SUPPL | 22 | AP | 2003-07-16 | |
| S; Supplement | SUPPL | 23 | AP | 2003-11-13 | |
| S; Supplement | SUPPL | 24 | AP | 2004-06-01 | |
| S; Supplement | SUPPL | 25 | AP | 2004-12-16 | |
| S; Supplement | SUPPL | 26 | AP | 2004-12-16 | |
| S; Supplement | SUPPL | 28 | AP | 2004-12-24 | |
| LABELING; Labeling | SUPPL | 40 | AP | 2011-06-24 | |
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 | 14 | 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 | 28 | Null | 0 |
| SUPPL | 40 | Null | 0 |
CDER Filings
MALLINCKRODT
cder:Array
(
[0] => Array
(
[ApplNo] => 40084
[companyName] => MALLINCKRODT
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"750MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"660MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"650MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"750MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"660MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"650MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)