Application Sponsors
| ANDA 078552 | EPIC PHARMA LLC | |
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
| ORIG | 1 | AP | 2009-04-08 | |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 3 | AP | 2015-01-27 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2013-08-30 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2015-10-19 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2018-04-26 | STANDARD |
Submissions Property Types
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 10 | Null | 31 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
EPIC PHARMA LLC
cder:Array
(
[0] => Array
(
[ApplNo] => 78552
[companyName] => EPIC PHARMA LLC
[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":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"AMLODIPINE BESYLATE","submission":"AMLODIPINE BESYLATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)