Application Sponsors
ANDA 206194 | HISUN PHARM HANGZHOU | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET;ORAL | 75MG | 0 | IRBESARTAN | IRBESARTAN |
002 | TABLET;ORAL | 150MG | 0 | IRBESARTAN | IRBESARTAN |
003 | TABLET;ORAL | 300MG | 0 | IRBESARTAN | IRBESARTAN |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-06-14 | STANDARD |
LABELING; Labeling | SUPPL | 2 | AP | 2018-11-02 | STANDARD |
Submissions Property Types
TE Codes
001 | Prescription | AB |
002 | Prescription | AB |
003 | Prescription | AB |
CDER Filings
HISUN PHARM HANGZHOU
cder:Array
(
[0] => Array
(
[ApplNo] => 206194
[companyName] => HISUN PHARM HANGZHOU
[docInserts] => ["",""]
[products] => [{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/14\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-11-02
)
)