YAOPHARMA CO LTD FDA Approval ANDA 072151

ANDA 072151

YAOPHARMA CO LTD

FDA Drug Application

Application #072151

Application Sponsors

ANDA 072151YAOPHARMA CO LTD

Marketing Status

Discontinued001
Discontinued002

Application Products

001TABLET;ORALEQ 2MG BASE0ALBUTEROL SULFATEALBUTEROL SULFATE
002TABLET;ORALEQ 4MG BASE0ALBUTEROL SULFATEALBUTEROL SULFATE

FDA Submissions

ORIG1AP1989-03-23
LABELING; LabelingSUPPL2AP1990-12-18
LABELING; LabelingSUPPL3AP1991-05-10
LABELING; LabelingSUPPL4AP1993-10-06
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1994-08-23
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1994-08-23
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1994-08-23
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1994-01-24
LABELING; LabelingSUPPL10AP1994-08-23
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1995-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1997-11-05
LABELING; LabelingSUPPL13AP1998-04-23
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1999-05-05
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2000-11-30
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2002-02-07
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2001-12-13
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2002-04-19

Submissions Property Types

SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL11Null0
SUPPL12Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0

CDER Filings

YAOPHARMA CO LTD
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 72151
            [companyName] => YAOPHARMA CO LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALBUTEROL SULFATE","activeIngredients":"ALBUTEROL SULFATE","strength":"EQ 2MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ALBUTEROL SULFATE","submission":"ALBUTEROL SULFATE","actionType":"EQ 2MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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