Application Sponsors
Marketing Status
Application Products
| 001 | TABLET;ORAL | 500MG;5MG | 0 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE |
FDA Submissions
| ORIG | 1 | AP | 1986-07-16 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 1988-04-15 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 1988-06-17 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1993-07-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1993-07-20 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1989-03-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 1989-03-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 1989-03-02 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 1990-09-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 1990-09-14 | |
| BIOEQUIV; Bioequivalence | SUPPL | 16 | AP | 1989-04-11 | |
| LABELING; Labeling | SUPPL | 17 | AP | 1989-11-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 19 | AP | 1991-02-21 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 20 | AP | 1992-01-06 | |
| LABELING; Labeling | SUPPL | 21 | AP | 1992-01-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 22 | AP | 1992-01-06 | |
| LABELING; Labeling | SUPPL | 23 | AP | 1992-01-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 24 | AP | 1992-01-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 25 | AP | 1992-01-06 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 26 | AP | 1992-05-13 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 1995-02-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 28 | AP | 1995-07-19 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 29 | AP | 2000-08-31 | |
| LABELING; Labeling | SUPPL | 30 | AP | 1997-02-07 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 31 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 32 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 33 | AP | 2000-08-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 34 | AP | 1996-09-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 35 | AP | 1996-09-18 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 36 | AP | 1998-01-14 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 37 | AP | 1998-07-31 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 38 | AP | 1998-09-09 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 39 | AP | 2002-08-13 | |
Submissions Property Types
| ORIG | 1 | Null | 0 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 4 | 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 | 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 | 28 | Null | 0 |
| SUPPL | 29 | Null | 0 |
| SUPPL | 30 | Null | 0 |
| SUPPL | 31 | Null | 0 |
| SUPPL | 32 | Null | 0 |
| SUPPL | 33 | Null | 0 |
| SUPPL | 34 | Null | 0 |
| SUPPL | 35 | Null | 0 |
| SUPPL | 36 | Null | 0 |
| SUPPL | 37 | Null | 0 |
| SUPPL | 38 | Null | 0 |
| SUPPL | 39 | Null | 0 |
CDER Filings
MIKART
cder:Array
(
[0] => Array
(
[ApplNo] => 89271
[companyName] => MIKART
[docInserts] => ["",""]
[products] => [{"drugName":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","strength":"500MG;5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"HYDROCODONE BITARTRATE AND ACETAMINOPHEN","submission":"ACETAMINOPHEN; HYDROCODONE BITARTRATE","actionType":"500MG;5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)