ANDA 202906

DR REDDYS LABS LTD

FDA Drug Application

Application #202906

Application Sponsors

ANDA 202906

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

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

001

Prescription

AB

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
        )

)