Application Sponsors
| ANDA 090084 | ACTAVIS LABS FL INC | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | 325MG;4.8355MG | 0 | OXYCODONE AND ASPIRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2011-03-22 | |
| REMS; REMS | SUPPL | 5 | AP | 2018-09-18 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2018-09-11 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2018-09-21 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2021-03-04 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-05-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 10 | Null | 15 |
| SUPPL | 11 | Null | 7 |
TE Codes
CDER Filings
ACTAVIS LABS FL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 90084
[companyName] => ACTAVIS LABS FL INC
[docInserts] => ["",""]
[products] => [{"drugName":"OXYCODONE AND ASPIRIN","activeIngredients":"ASPIRIN; OXYCODONE HYDROCHLORIDE","strength":"325MG;4.8355MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"OXYCODONE AND ASPIRIN","submission":"ASPIRIN; OXYCODONE HYDROCHLORIDE","actionType":"325MG;4.8355MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)