ACTAVIS MID ATLANTIC FDA Approval ANDA 074128

ANDA 074128

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #074128

Application Sponsors

ANDA 074128ACTAVIS MID ATLANTIC

Marketing Status

Discontinued001

Application Products

001OINTMENT;TOPICAL0.05%0CLOBETASOL PROPIONATECLOBETASOL PROPIONATE

FDA Submissions

ORIG1AP1994-08-03
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1995-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1996-08-15
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1996-08-15
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1996-08-15
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1996-08-15
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1996-06-28
LABELING; LabelingSUPPL8AP1998-01-07
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2000-12-29
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2002-05-31
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2002-05-31
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2002-08-29
LABELING; LabelingSUPPL13AP2002-08-29
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2001-05-30
LABELING; LabelingSUPPL16AP2004-05-18

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL14Null0

CDER Filings

ACTAVIS MID ATLANTIC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74128
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CLOBETASOL PROPIONATE","activeIngredients":"CLOBETASOL PROPIONATE","strength":"0.05%","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CLOBETASOL PROPIONATE","submission":"CLOBETASOL PROPIONATE","actionType":"0.05%","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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