SUN PHARM INDS INC FDA Approval ANDA 040587

ANDA 040587

SUN PHARM INDS INC

FDA Drug Application

Application #040587

Application Sponsors

ANDA 040587SUN PHARM INDS INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001CAPSULE;ORAL100MG0BENZONATATEBENZONATATE
002CAPSULE;ORAL200MG0BENZONATATEBENZONATATE

FDA Submissions

ORIG1AP2008-03-19
LABELING; LabelingSUPPL5AP2011-04-26

CDER Filings

SUN PHARM INDS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40587
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BENZONATATE","activeIngredients":"BENZONATATE","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BENZONATATE","submission":"BENZONATATE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BENZONATATE","submission":"BENZONATATE","actionType":"200MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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