Application Sponsors
ANDA 088790 | JANSSEN PHARMS | |
Marketing Status
Application Products
001 | CAPSULE;ORAL | 500MG;5MG | 0 | TYLOX | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 1984-12-12 | |
LABELING; Labeling | SUPPL | 8 | AP | 1991-05-30 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 9 | AP | 1996-03-25 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 10 | AP | 1997-01-06 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 1998-04-03 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 12 | AP | 2001-01-24 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 14 | AP | 2002-07-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 15 | AP | 2002-07-31 | |
MANUF (CMC); Manufacturing (CMC) | SUPPL | 16 | AP | 2001-11-30 | |
Submissions Property Types
ORIG | 1 | Null | 0 |
SUPPL | 8 | Null | 0 |
SUPPL | 9 | Null | 0 |
SUPPL | 10 | Null | 0 |
SUPPL | 11 | Null | 0 |
SUPPL | 12 | Null | 0 |
SUPPL | 14 | Null | 0 |
SUPPL | 15 | Null | 0 |
SUPPL | 16 | Null | 0 |
CDER Filings
JANSSEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 88790
[companyName] => JANSSEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"TYLOX","activeIngredients":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","strength":"500MG;5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"TYLOX","submission":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","actionType":"500MG;5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)