Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG;7.5MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1989-08-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1991-06-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1991-06-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1991-06-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1991-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1991-07-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1992-01-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1993-02-25 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1993-06-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1993-02-25 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1997-01-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1995-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 18 | AP | 1995-07-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1996-09-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1996-09-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 1998-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 1998-09-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2002-08-13 | |
| LABELING; Labeling | SUPPL | 32 | AP | 2002-11-20 | |
| LABELING; Labeling | SUPPL | 44 | AP | 2013-10-18 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | 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 | 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 | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 44 | Null | 0 |
CDER Filings
MIKART
cder:Array
(
[0] => Array
(
[ApplNo] => 89699
[companyName] => MIKART
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"10\/18\/2013","submission":"SUPPL-44","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2013-10-18
)
)