Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG;5MG | 0 | CO-GESIC | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1982-05-03 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1984-01-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1984-01-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1985-05-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1986-04-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1992-10-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1989-04-20 | |
| LABELING; Labeling | SUPPL | 15 | AP | 1989-02-07 | |
| LABELING; Labeling | SUPPL | 16 | AP | 1990-03-29 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1989-05-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1991-08-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1995-12-06 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1995-12-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1995-12-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 1995-12-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1994-12-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1996-04-30 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1998-12-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1999-11-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 30 | AP | 2008-01-26 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 14 | Null | 0 |
| SUPPL | 15 | Null | 0 |
| SUPPL | 16 | Null | 0 |
| SUPPL | 17 | 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 | 30 | Null | 0 |
CDER Filings
UCB INC
cder:Array
(
[0] => Array
(
[ApplNo] => 87757
[companyName] => UCB INC
[docInserts] => ["",""]
[products] => [{"drugName":"CO-GESIC","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CO-GESIC","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)