ACTAVIS LABS FL INC FDA Approval ANDA 075270

ANDA 075270

ACTAVIS LABS FL INC

FDA Drug Application

Application #075270

Documents

Letter1999-03-24

Application Sponsors

ANDA 075270ACTAVIS LABS FL INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003

Application Products

001CAPSULE, EXTENDED RELEASE;ORAL200MG0KETOPROFENKETOPROFEN
002CAPSULE, EXTENDED RELEASE;ORAL100MG0KETOPROFENKETOPROFEN
003CAPSULE, EXTENDED RELEASE;ORAL150MG0KETOPROFENKETOPROFEN

FDA Submissions

ORIG1AP1999-03-24
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2002-09-20
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-12-24
LABELING; LabelingSUPPL7AP2006-07-03
LABELING; LabelingSUPPL8AP2006-09-22
LABELING; LabelingSUPPL10AP2008-02-21
LABELING; LabelingSUPPL13AP2016-05-09STANDARD
LABELING; LabelingSUPPL14AP2021-04-28STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL13Null15
SUPPL14Null7

CDER Filings

ACTAVIS LABS FL INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75270
            [companyName] => ACTAVIS LABS FL INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"KETOPROFEN","activeIngredients":"KETOPROFEN","strength":"150MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"200MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"100MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"KETOPROFEN","submission":"KETOPROFEN","actionType":"150MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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