CIPLA FDA Approval ANDA 207463

ANDA 207463

CIPLA

FDA Drug Application

Application #207463

Application Sponsors

ANDA 207463CIPLA

Marketing Status

Prescription001

Application Products

001TABLET;ORALEQ 10MG BASE0MONTELUKAST SODIUMMONTELUKAST SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2016-10-28STANDARD
LABELING; LabelingSUPPL2AP2020-07-23STANDARD
LABELING; LabelingSUPPL3AP2020-07-23STANDARD
LABELING; LabelingSUPPL4AP2020-07-23STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null15
SUPPL3Null15
SUPPL4Null7

TE Codes

001PrescriptionAB

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
        )

)

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