Application Sponsors
| ANDA 203245 | UNICHEM LABS LTD | |
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 | 2013-10-21 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-01-19 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2017-01-04 | UNKNOWN |
| LABELING; Labeling | SUPPL | 10 | AP | 2018-04-26 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 31 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 10 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
UNICHEM LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203245
[companyName] => UNICHEM LABS LTD
[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":"10\/21\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/26\/2018","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/04\/2017","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/19\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-04-26
)
)