YAOPHARMA CO LTD FDA Approval ANDA 040196

ANDA 040196

YAOPHARMA CO LTD

FDA Drug Application

Application #040196

Application Sponsors

ANDA 040196YAOPHARMA CO LTD

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005
Discontinued006
Discontinued007
Discontinued008
Discontinued009

Application Products

001TABLET;ORAL1MG0WARFARIN SODIUMWARFARIN SODIUM
002TABLET;ORAL2MG0WARFARIN SODIUMWARFARIN SODIUM
003TABLET;ORAL2.5MG0WARFARIN SODIUMWARFARIN SODIUM
004TABLET;ORAL4MG0WARFARIN SODIUMWARFARIN SODIUM
005TABLET;ORAL5MG0WARFARIN SODIUMWARFARIN SODIUM
006TABLET;ORAL7.5MG0WARFARIN SODIUMWARFARIN SODIUM
007TABLET;ORAL10MG0WARFARIN SODIUMWARFARIN SODIUM
008TABLET;ORAL3MG0WARFARIN SODIUMWARFARIN SODIUM
009TABLET;ORAL6MG0WARFARIN SODIUMWARFARIN SODIUM

FDA Submissions

ORIG1AP1997-09-30
LABELING; LabelingSUPPL2AP2000-01-05
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2000-02-23
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2000-07-26
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-07-26
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2000-07-26
LABELING; LabelingSUPPL7AP2000-07-26
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2002-04-15
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2002-04-15
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2002-04-15

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0

CDER Filings

YAOPHARMA CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40196
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"7.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"WARFARIN SODIUM","activeIngredients":"WARFARIN SODIUM","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"2.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"7.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"WARFARIN SODIUM","submission":"WARFARIN SODIUM","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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