CONTRACT PHARMACAL FDA Approval ANDA 073691

ANDA 073691

CONTRACT PHARMACAL

FDA Drug Application

Application #073691

Application Sponsors

ANDA 073691CONTRACT PHARMACAL

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL200MG0IBUPROFENIBUPROFEN

FDA Submissions

ORIG1AP1994-02-25
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1996-07-24
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-07-23
LABELING; LabelingSUPPL5AP1999-12-01
LABELING; LabelingSUPPL6AP2006-03-22

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0

CDER Filings

CONTRACT PHARMACAL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 73691
            [companyName] => CONTRACT PHARMACAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IBUPROFEN","submission":"IBUPROFEN","actionType":"200MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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