ACTAVIS MID ATLANTIC FDA Approval ANDA 070051

ANDA 070051

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #070051

Application Sponsors

ANDA 070051ACTAVIS MID ATLANTIC

Marketing Status

Prescription001

Application Products

001OINTMENT;TOPICALEQ 0.1% BASE0BETAMETHASONE VALERATEBETAMETHASONE VALERATE

FDA Submissions

ORIG1AP1984-10-10
LABELING; LabelingSUPPL3AP1992-07-29
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1989-09-11
MANUF (CMC); Manufacturing (CMC)SUPPL5AP1993-01-29
LABELING; LabelingSUPPL6AP1994-04-15
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1996-06-10
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1996-06-10
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1996-02-07
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1996-06-28
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1996-09-13
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1996-09-13
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1996-09-13
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1996-09-13
MANUF (CMC); Manufacturing (CMC)SUPPL15AP2000-12-29
MANUF (CMC); Manufacturing (CMC)SUPPL16AP2001-05-30
MANUF (CMC); Manufacturing (CMC)SUPPL17AP2001-08-31

Submissions Property Types

SUPPL4Null0
SUPPL5Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL13Null0
SUPPL14Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0

TE Codes

001PrescriptionAB

CDER Filings

ACTAVIS MID ATLANTIC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70051
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE VALERATE","activeIngredients":"BETAMETHASONE VALERATE","strength":"EQ 0.1% BASE","dosageForm":"OINTMENT;TOPICAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BETAMETHASONE VALERATE","submission":"BETAMETHASONE VALERATE","actionType":"EQ 0.1% BASE","submissionClassification":"OINTMENT;TOPICAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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