TARO FDA Approval ANDA 086275

ANDA 086275

TARO

FDA Drug Application

Application #086275

Application Sponsors

ANDA 086275TARO

Marketing Status

Discontinued001

Application Products

001CREAM;TOPICAL0.5%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE

FDA Submissions

ORIG1AP1979-04-10
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1982-04-28
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1983-07-07
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1984-06-12
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1985-12-03
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1986-10-07
MANUF (CMC); Manufacturing (CMC)SUPPL22AP1988-10-27
MANUF (CMC); Manufacturing (CMC)SUPPL25AP1989-05-11
LABELING; LabelingSUPPL26AP1989-02-07
MANUF (CMC); Manufacturing (CMC)SUPPL27AP1990-01-03
LABELING; LabelingSUPPL29AP1990-11-20
LABELING; LabelingSUPPL30AP1991-03-18
LABELING; LabelingSUPPL32AP1992-11-16
LABELING; LabelingSUPPL33AP1993-04-08

Submissions Property Types

SUPPL9Null0
SUPPL12Null0
SUPPL13Null0
SUPPL17Null0
SUPPL20Null0
SUPPL22Null0
SUPPL25Null0
SUPPL27Null0

CDER Filings

TARO
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86275
            [companyName] => TARO
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.5%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.5%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.