L PERRIGO CO FDA Approval ANDA 075367

ANDA 075367

L PERRIGO CO

FDA Drug Application

Application #075367

Application Sponsors

ANDA 075367L PERRIGO CO

Marketing Status

Over-the-counter001

Application Products

001TABLET;ORAL100MG0JUNIOR STRENGTH IBUPROFENIBUPROFEN

FDA Submissions

ORIG1AP1999-04-22
LABELING; LabelingSUPPL2AP2001-04-12
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2001-08-21
LABELING; LabelingSUPPL18AP2006-03-17

Submissions Property Types

SUPPL3Null0

CDER Filings

L PERRIGO CO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75367
            [companyName] => L PERRIGO CO
            [docInserts] => ["",""]
            [products] => [{"drugName":"JUNIOR STRENGTH IBUPROFEN","activeIngredients":"IBUPROFEN","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"JUNIOR STRENGTH IBUPROFEN","submission":"IBUPROFEN","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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