SUN PHARM INDS LTD FDA Approval ANDA 091466

ANDA 091466

SUN PHARM INDS LTD

FDA Drug Application

Application #091466

Application Sponsors

ANDA 091466SUN PHARM INDS LTD

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL2.5MG0LETROZOLELETROZOLE

FDA Submissions

ORIG1AP2011-06-03
LABELING; LabelingSUPPL2AP2015-02-17STANDARD

Submissions Property Types

ORIG1Null42
SUPPL2Null7

CDER Filings

SUN PHARM INDS LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91466
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"LETROZOLE","activeIngredients":"LETROZOLE","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LETROZOLE","submission":"LETROZOLE","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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