ANDA 213471

AUROBINDO PHARMA LTD

FDA Drug Application

Application #213471

Application Sponsors

ANDA 213471

AUROBINDO 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	2020-02-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-07-30	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AB

CDER Filings

AUROBINDO PHARMA LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213471
            [companyName] => AUROBINDO 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":"02\/18\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-18
        )

)