ANDA 201582

DR REDDYS LABS LTD

FDA Drug Application

Application #201582

Application Sponsors

ANDA 201582

DR REDDYS LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 10MG 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	3	AP	2013-02-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2013-08-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-11-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	2020-11-10	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-11-10	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-11-10	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-11-10	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	5	Null	15
SUPPL	8	Null	15
SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	7
SUPPL	16	Null	7

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201582
            [companyName] => DR REDDYS LABS 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":"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-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/19\/2013","submission":"SUPPL-3","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/05\/2013","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/10\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2013-08-06
        )

)