Application Sponsors
| ANDA 203366 | MACLEODS PHARMS LTD | |
Marketing Status
Application Products
| 001 | TABLET;ORAL | EQ 10MG BASE | 0 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-09-11 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2018-05-18 | STANDARD |
| LABELING; Labeling | SUPPL | 13 | AP | 2019-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2019-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2020-11-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 13 | Null | 15 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 20 | Null | 7 |
TE Codes
CDER Filings
MACLEODS PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203366
[companyName] => MACLEODS PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/11\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/08\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2019","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/18\/2018","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/23\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-08
)
)