Application Sponsors
ANDA 202965 | DR REDDYS LABS 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 | 2013-06-03 | |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202965
[companyName] => DR REDDYS LABS 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":"06\/03\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2013-06-03
)
)