Application Sponsors
| ANDA 076862 | ACTAVIS LABS FL INC | |
Marketing Status
| Prescription | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG TARTRATE | 0 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE |
| 002 | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG TARTRATE | 0 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE |
FDA Submissions
| ORIG | 1 | AP | 2009-08-03 | |
| LABELING; Labeling | SUPPL | 6 | AP | 2015-06-29 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2014-05-15 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2015-06-29 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 17 | Null | 7 |
TE Codes
CDER Filings
ACTAVIS LABS FL INC
cder:Array
(
[0] => Array
(
[ApplNo] => 76862
[companyName] => ACTAVIS LABS FL INC
[docInserts] => ["",""]
[products] => [{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 50MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 25MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METOPROLOL SUCCINATE","submission":"METOPROLOL SUCCINATE","actionType":"EQ 50MG TARTRATE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL SUCCINATE","submission":"METOPROLOL SUCCINATE","actionType":"EQ 25MG TARTRATE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)