SUN PHARM INDUSTRIES FDA Approval ANDA 077635

ANDA 077635

SUN PHARM INDUSTRIES

FDA Drug Application

Application #077635

Documents

Letter2006-01-18
Healthcare Professional Sheet2008-02-01

Application Sponsors

ANDA 077635SUN PHARM INDUSTRIES

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001CAPSULE;ORAL25MG0ZONISAMIDEZONISAMIDE
002CAPSULE;ORAL50MG0ZONISAMIDEZONISAMIDE
003CAPSULE;ORAL100MG0ZONISAMIDEZONISAMIDE

FDA Submissions

ORIG1AP2005-12-22

CDER Filings

SUN PHARM INDUSTRIES
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77635
            [companyName] => SUN PHARM INDUSTRIES
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"25MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZONISAMIDE","activeIngredients":"ZONISAMIDE","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"25MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"50MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZONISAMIDE","submission":"ZONISAMIDE","actionType":"100MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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