Application Sponsors
| ANDA 201581 | DR REDDYS LABS LTD | |
Marketing Status
| Prescription | 001 |
| Prescription | 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 | 2012-08-06 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2013-02-05 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2013-08-06 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2020-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2020-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2020-11-10 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2020-11-10 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 6 | Null | 15 |
| SUPPL | 7 | Null | 7 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 9 | Null | 15 |
TE Codes
| 001 | Prescription | AB |
| 002 | Prescription | AB |
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 201581
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/06\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/06\/2013","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/05\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/10\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2013-08-06
)
)