Application Sponsors
| ANDA 202776 | MYLAN PHARMS INC | |
Marketing Status
Application Products
| 001 | GRANULE;ORAL | EQ 4MG BASE/PACKET | 0 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2012-12-18 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2015-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-10-08 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2020-08-18 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 7 |
| SUPPL | 10 | Null | 7 |
CDER Filings
MYLAN PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 202776
[companyName] => MYLAN PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE\/PACKET","dosageForm":"GRANULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/18\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/18\/2020","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/22\/2019","submission":"SUPPL-9","supplementCategories":"Labeling-Patient Package Insert, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/22\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/08\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/08\/2015","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2020-08-18
)
)