ANDA 203438

AJANTA PHARMA LTD

FDA Drug Application

Application #203438

Application Sponsors

ANDA 203438

AJANTA PHARMA 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	2015-07-31
LABELING; Labeling	SUPPL	6	AP	2019-11-08	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-11-08	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-10-20	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	7
SUPPL	10	Null	15
SUPPL	16	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AJANTA PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203438
            [companyName] => AJANTA PHARMA 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":"07\/31\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/08\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/08\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-08
        )

)