ANDA 210431

TORRENT

FDA Drug Application

Application #210431

Application Sponsors

ANDA 210431

TORRENT

Marketing Status

• Prescription: 001

Application Products

001

GRANULE;ORAL

EQ 4MG BASE/PACKET

0

MONTELUKAST SODIUM

MONTELUKAST SODIUM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2018-07-31	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-11-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	2020-11-24	STANDARD
LABELING; Labeling	SUPPL	4	AP	2021-10-15	STANDARD

Submissions Property Types

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

TE Codes

001

Prescription

AB

CDER Filings

TORRENT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210431
            [companyName] => TORRENT
            [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\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-07-31
        )

)