Documents
Application Sponsors
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | TABLET, CHEWABLE;ORAL | EQ 4MG BASE | 0 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
| 002 | TABLET, CHEWABLE;ORAL | EQ 5MG BASE | 0 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
FDA Submissions
| N/A; Not Applicable | ORIG | 1 | AP | 2012-08-03 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-08-14 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-03-16 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2015-03-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 15 |
CDER Filings
APOTEX INC
cder:Array
(
[0] => Array
(
[ApplNo] => 201508
[companyName] => APOTEX INC
[docInserts] => ["",""]
[products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/03\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/201508Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"03\/16\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/16\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/14\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/13\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-03-16
)
)