Documents
Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG;5MG | 0 | VICODIN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1983-01-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1984-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 1984-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 5 | AP | 1984-11-26 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 6 | AP | 1986-06-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 7 | AP | 1986-06-24 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 8 | AP | 1987-05-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1987-05-11 | |
| S; Supplement | SUPPL | 11 | AP | 1987-05-11 | |
| S; Supplement | SUPPL | 12 | AP | 1987-05-11 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1988-02-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1988-02-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 17 | AP | 1988-01-19 | |
| LABELING; Labeling | SUPPL | 18 | AP | 1992-08-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1992-08-20 | |
| LABELING; Labeling | SUPPL | 20 | AP | 1992-09-10 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 21 | AP | 2000-02-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 2000-03-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 23 | AP | 2000-06-27 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 2001-04-02 | |
| LABELING; Labeling | SUPPL | 27 | AP | 2006-12-26 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 3 | Null | 0 |
| SUPPL | 5 | Null | 0 |
| SUPPL | 6 | Null | 0 |
| SUPPL | 7 | Null | 0 |
| SUPPL | 8 | Null | 0 |
| SUPPL | 9 | Null | 0 |
| SUPPL | 11 | Null | 0 |
| SUPPL | 12 | Null | 0 |
| SUPPL | 13 | Null | 0 |
| SUPPL | 14 | 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 | 27 | Null | 0 |
CDER Filings
ABBVIE
cder:Array
(
[0] => Array
(
[ApplNo] => 88058
[companyName] => ABBVIE
[docInserts] => ["",""]
[products] => [{"drugName":"VICODIN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"12\/26\/2006","submission":"SUPPL-27","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/088058s027lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"VICODIN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 2006-12-26
)
)