Application Sponsors
Marketing Status
Application Products
001 | TABLET;ORAL | 660MG;10MG | 0 | VICODIN HP | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1996-09-23 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2000-06-27 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2001-05-01 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 2 | Null | 0 |
SUPPL | 3 | Null | 0 |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 40117
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"VICODIN HP","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"660MG;10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"VICODIN HP","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"660MG;10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)