Application Sponsors
Marketing Status
Discontinued | 001 |
Discontinued | 002 |
Discontinued | 003 |
Application Products
001 | TABLET;ORAL | EQ 2.5MG BASE | 0 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE |
002 | TABLET;ORAL | EQ 5MG BASE | 0 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE |
003 | TABLET;ORAL | EQ 10MG BASE | 0 | AMLODIPINE BESYLATE | AMLODIPINE BESYLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-05-04 | STANDARD |
Submissions Property Types
CDER Filings
SUNSHINE
cder:Array
(
[0] => Array
(
[ApplNo] => 206524
[companyName] => SUNSHINE
[docInserts] => ["",""]
[products] => [{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-05-04
)
)