Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 650MG;10MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1992-05-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1994-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1994-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1994-02-08 | |
| LABELING; Labeling | SUPPL | 5 | AP | 1994-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1993-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1993-07-12 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1995-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1995-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 2000-08-31 | |
| LABELING; Labeling | SUPPL | 11 | AP | 1996-11-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1996-09-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 1996-09-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1998-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 2002-08-13 | |
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 | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | Null | 0 |
| SUPPL | 18 | Null | 0 |
CDER Filings
MIKART
cder:Array
(
[0] => Array
(
[ApplNo] => 81223
[companyName] => MIKART
[docInserts] => ["",""]
[products] => [{"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":"650MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)