ACTAVIS MID ATLANTIC FDA Approval ANDA 087798

ANDA 087798

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #087798

Application Sponsors

ANDA 087798ACTAVIS MID ATLANTIC

Marketing Status

Discontinued001

Application Products

001CREAM;TOPICAL0.1%0TRIAMCINOLONE ACETONIDETRIAMCINOLONE ACETONIDE

FDA Submissions

ORIG1AP1982-06-04
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1983-03-21
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1983-03-31
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1985-12-20
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1988-06-15
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1988-06-15
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1989-07-26
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1989-07-26
LABELING; LabelingSUPPL13AP1991-02-11
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1995-07-24
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1996-02-07
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1997-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1997-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL18AP1997-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL19AP1997-06-23
MANUF (CMC); Manufacturing (CMC)SUPPL20AP1996-06-28
MANUF (CMC); Manufacturing (CMC)SUPPL21AP1997-05-12
MANUF (CMC); Manufacturing (CMC)SUPPL22AP2000-09-25
MANUF (CMC); Manufacturing (CMC)SUPPL23AP2000-12-29
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2001-05-30

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL9Null0
SUPPL11Null0
SUPPL12Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0
SUPPL18Null0
SUPPL19Null0
SUPPL20Null0
SUPPL21Null0
SUPPL22Null0
SUPPL23Null0
SUPPL24Null0

CDER Filings

ACTAVIS MID ATLANTIC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 87798
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TRIAMCINOLONE ACETONIDE","activeIngredients":"TRIAMCINOLONE ACETONIDE","strength":"0.1%","dosageForm":"CREAM;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TRIAMCINOLONE ACETONIDE","submission":"TRIAMCINOLONE ACETONIDE","actionType":"0.1%","submissionClassification":"CREAM;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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