Application Sponsors
ANDA 202906 | DR REDDYS LABS LTD | |
Marketing Status
Application Products
001 | GRANULE;ORAL | EQ 4MG BASE/PACKET | 0 | MONTELUKAST SODIUM | MONTELUKAST SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2012-09-17 | |
LABELING; Labeling | SUPPL | 2 | AP | 2013-01-31 | STANDARD |
LABELING; Labeling | SUPPL | 3 | AP | 2013-08-14 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2019-11-07 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2019-11-07 | STANDARD |
LABELING; Labeling | SUPPL | 10 | AP | 2019-11-07 | STANDARD |
LABELING; Labeling | SUPPL | 11 | AP | 2019-11-07 | STANDARD |
LABELING; Labeling | SUPPL | 12 | AP | 2019-11-07 | STANDARD |
LABELING; Labeling | SUPPL | 13 | AP | 2020-11-05 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 15 |
SUPPL | 2 | Null | 15 |
SUPPL | 3 | Null | 15 |
SUPPL | 6 | Null | 15 |
SUPPL | 7 | Null | 7 |
SUPPL | 10 | Null | 15 |
SUPPL | 11 | Null | 15 |
SUPPL | 12 | Null | 7 |
SUPPL | 13 | Null | 7 |
TE Codes
CDER Filings
DR REDDYS LABS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202906
[companyName] => DR REDDYS LABS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE\/PACKET","dosageForm":"GRANULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/17\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"11\/07\/2019","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/07\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/07\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/07\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/07\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/14\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"01\/31\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/30\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-11-07
)
)