TARO FDA Approval ANDA 087902

ANDA 087902

TARO

FDA Drug Application

Application #087902

Application Sponsors

ANDA 087902TARO

Marketing Status

Discontinued001

Application Products

001OINTMENT;TOPICAL0.1%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE

FDA Submissions

ORIG1AP1982-12-27
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1984-06-14
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1984-06-14
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1985-12-03
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1986-01-30
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1987-09-08
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1987-09-15
LABELING; LabelingSUPPL16AP1988-04-21
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1990-01-22
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1990-03-28
LABELING; LabelingSUPPL20AP1989-02-07
LABELING; LabelingSUPPL21AP1989-03-02
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1990-01-22
LABELING; LabelingSUPPL23AP1989-11-21
LABELING; LabelingSUPPL24AP1990-03-01
LABELING; LabelingSUPPL25AP1990-08-06
LABELING; LabelingSUPPL28AP1991-03-05
LABELING; LabelingSUPPL29AP1991-10-28
LABELING; LabelingSUPPL30AP1992-11-16
LABELING; LabelingSUPPL31AP1993-04-08

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL7Null0
SUPPL9Null0
SUPPL12Null0
SUPPL15Null0
SUPPL18Null0
SUPPL19Null0
SUPPL22Null0

CDER Filings

TARO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87902
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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