MYLAN PHARMS INC FDA Approval ANDA 079142

ANDA 079142

MYLAN PHARMS INC

FDA Drug Application

Application #079142

Documents

Letter2012-08-06

Application Sponsors

ANDA 079142MYLAN PHARMS INC

Marketing Status

Discontinued001
Discontinued002

Application Products

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

FDA Submissions

ORIG1AP2012-08-03
LABELING; LabelingSUPPL2AP2012-12-12STANDARD
LABELING; LabelingSUPPL4AP2015-03-16STANDARD
LABELING; LabelingSUPPL5AP2015-03-16STANDARD
LABELING; LabelingSUPPL8AP2015-03-16STANDARD
LABELING; LabelingSUPPL9AP2015-10-08STANDARD
LABELING; LabelingSUPPL14AP2019-10-22STANDARD
LABELING; LabelingSUPPL15AP2019-10-22STANDARD
LABELING; LabelingSUPPL16AP2020-08-18STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null15
SUPPL4Null7
SUPPL5Null7
SUPPL8Null7
SUPPL9Null7
SUPPL14Null7
SUPPL15Null7
SUPPL16Null15

CDER Filings

MYLAN PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79142
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 4MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MONTELUKAST SODIUM","activeIngredients":"MONTELUKAST SODIUM","strength":"EQ 5MG BASE","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MONTELUKAST SODIUM","submission":"MONTELUKAST SODIUM","actionType":"EQ 4MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MONTELUKAST SODIUM","submission":"MONTELUKAST SODIUM","actionType":"EQ 5MG BASE","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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