Application Sponsors
ANDA 090617 | DR REDDYS LABS LTD | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG TARTRATE | 0 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE |
002 | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG TARTRATE | 0 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE |
FDA Submissions
| ORIG | 1 | AP | 2012-08-01 | |
LABELING; Labeling | SUPPL | 3 | AP | 2014-01-27 | STANDARD |
LABELING; Labeling | SUPPL | 5 | AP | 2015-12-16 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 5 | Null | 7 |
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 90617
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 25MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 50MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"METOPROLOL SUCCINATE","submission":"METOPROLOL SUCCINATE","actionType":"EQ 25MG TARTRATE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"METOPROLOL SUCCINATE","submission":"METOPROLOL SUCCINATE","actionType":"EQ 50MG TARTRATE","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)