YAOPHARMA CO LTD FDA Approval ANDA 071423

ANDA 071423

YAOPHARMA CO LTD

FDA Drug Application

Application #071423

Application Sponsors

ANDA 071423YAOPHARMA CO LTD

Marketing Status

Discontinued001

Application Products

001TABLET;ORAL80MG0VERAPAMIL HYDROCHLORIDEVERAPAMIL HYDROCHLORIDE

FDA Submissions

ORIG1AP1988-05-25
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1991-01-07
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1991-01-07
LABELING; LabelingSUPPL5AP1991-04-22
LABELING; LabelingSUPPL6AP1992-05-28
LABELING; LabelingSUPPL7AP1992-08-06
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1995-03-30
LABELING; LabelingSUPPL9AP1998-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1999-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2001-12-28
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2002-12-16

Submissions Property Types

SUPPL3Null0
SUPPL4Null0
SUPPL8Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0

CDER Filings

YAOPHARMA CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71423
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"VERAPAMIL HYDROCHLORIDE","activeIngredients":"VERAPAMIL HYDROCHLORIDE","strength":"80MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"VERAPAMIL HYDROCHLORIDE","submission":"VERAPAMIL HYDROCHLORIDE","actionType":"80MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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