Application Sponsors
| ANDA 204100 | MACLEODS PHARMS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 16MG;12.5MG | 0 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE |
| 002 | TABLET;ORAL | 32MG;12.5MG | 0 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE |
| 003 | TABLET;ORAL | 32MG;25MG | 0 | CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE | CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-02-27 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-06-23 | STANDARD |
| LABELING; Labeling | SUPPL | 18 | AP | 2021-05-13 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 18 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 204100
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE","strength":"16MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE","strength":"32MG;12.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE","activeIngredients":"CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE","strength":"32MG;25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/27\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"06\/23\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/23\/2016","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2016-06-23
)
)