Application Sponsors
ANDA 205541 | HETERO LABS LTD III | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Prescription | 004 |
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 |
003 | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG TARTRATE | 0 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE |
004 | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG TARTRATE | 0 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-11-06 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
004 | Prescription | AB |
CDER Filings
HETERO LABS LTD III
cder:Array
(
[0] => Array
(
[ApplNo] => 205541
[companyName] => HETERO LABS LTD III
[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"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 100MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"METOPROLOL SUCCINATE","activeIngredients":"METOPROLOL SUCCINATE","strength":"EQ 200MG TARTRATE","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-11-06
)
)