AMNEAL PHARMS FDA Approval ANDA 205107

ANDA 205107

AMNEAL PHARMS

FDA Drug Application

Application #205107

Application Sponsors

ANDA 205107AMNEAL PHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001TABLET, CHEWABLE;ORALEQ 4MG BASE0MONTELUKAST SODIUMMONTELUKAST SODIUM
002TABLET, CHEWABLE;ORALEQ 5MG BASE0MONTELUKAST SODIUMMONTELUKAST SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2020-09-04STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

AMNEAL PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205107
            [companyName] => AMNEAL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/04\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-09-04
        )

)

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