Application Sponsors
| ANDA 202910 | HETERO LABS LTD V | |
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 | 2012-09-27 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2016-08-09 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-11-06 | STANDARD |
| LABELING; Labeling | SUPPL | 15 | AP | 2022-02-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 10 | Null | 7 |
| SUPPL | 15 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
| 003 | Prescription | AB |
CDER Filings
HETERO LABS LTD V
cder:Array
(
[0] => Array
(
[ApplNo] => 202910
[companyName] => HETERO LABS LTD V
[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":"09\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/06\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/09\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/09\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/06\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-06
)
)