YAOPHARMA CO LTD FDA Approval ANDA 070290

ANDA 070290

YAOPHARMA CO LTD

FDA Drug Application

Application #070290

Application Sponsors

ANDA 070290YAOPHARMA CO LTD

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL500MG0TOLAZAMIDETOLAZAMIDE

FDA Submissions

ORIG1AP1986-03-13
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1987-12-23
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1987-12-23
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1988-11-08
LABELING; LabelingSUPPL6AP1989-05-09
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1990-03-14
LABELING; LabelingSUPPL8AP1992-07-24
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1995-10-24
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1996-04-03
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2001-05-09

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL7Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0

CDER Filings

YAOPHARMA CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70290
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLAZAMIDE","activeIngredients":"TOLAZAMIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOLAZAMIDE","submission":"TOLAZAMIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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