Documents
Application Sponsors
| ANDA 202012 | MYLAN PHARMS INC | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET;ORAL | EQ 400MG BASE | 0 | EPROSARTAN MESYLATE | EPROSARTAN MESYLATE |
| 002 | TABLET;ORAL | EQ 600MG BASE | 0 | EPROSARTAN MESYLATE | EPROSARTAN MESYLATE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2011-11-16 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-11-20 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-11-20 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 7 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202012
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"EPROSARTAN MESYLATE","activeIngredients":"EPROSARTAN MESYLATE","strength":"EQ 400MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"EPROSARTAN MESYLATE","activeIngredients":"EPROSARTAN MESYLATE","strength":"EQ 600MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"11\/16\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202012s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/20\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/20\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/20\/2013","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-11-20
)
)