ANDA 207463

CIPLA

FDA Drug Application

Application #207463

Application Sponsors

ANDA 207463

CIPLA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 10MG BASE

0

MONTELUKAST SODIUM

MONTELUKAST SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-07-23	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-07-23	STANDARD
LABELING; Labeling	SUPPL	4	AP	2020-07-23	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207463
            [companyName] => CIPLA
            [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":"10\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/23\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/23\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/23\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/14\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-23
        )

)