SUN PHARM INDS INC FDA Approval ANDA 077067

ANDA 077067

SUN PHARM INDS INC

FDA Drug Application

Application #077067

Documents

Letter2007-04-25

Application Sponsors

ANDA 077067SUN PHARM INDS INC

Marketing Status

Discontinued001

Application Products

001CAPSULE;ORAL30MG0NIMODIPINENIMODIPINE

FDA Submissions

ORIG1AP2007-04-17
LABELING; LabelingSUPPL11AP2010-03-30
LABELING; LabelingSUPPL14AP2012-01-18

Submissions Property Types

SUPPL11Null7
SUPPL14Null15

CDER Filings

SUN PHARM INDS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77067
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIMODIPINE","activeIngredients":"NIMODIPINE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NIMODIPINE","submission":"NIMODIPINE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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