Application Sponsors
| ANDA 200461 | MYLAN PHARMS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
| Discontinued | 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
| N/A; Not Applicable | ORIG | 1 | AP | 2012-09-27 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2018-11-02 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-08-04 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 7 |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 200461
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"75MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IRBESARTAN","activeIngredients":"IRBESARTAN","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/27\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/02\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-11-02
)
)