Application Sponsors
ANDA 207821 | POLYGEN PHARMS | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 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 | 2016-07-11 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2018-04-23 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
POLYGEN PHARMS
cder:Array
(
[0] => Array
(
[ApplNo] => 207821
[companyName] => POLYGEN PHARMS
[docInserts] => ["",""]
[products] => [{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"AMLODIPINE BESYLATE","activeIngredients":"AMLODIPINE BESYLATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/11\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/23\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/23\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-04-23
)
)