ACTAVIS MID ATLANTIC FDA Approval ANDA 070281

ANDA 070281

ACTAVIS MID ATLANTIC

FDA Drug Application

Application #070281

Application Sponsors

ANDA 070281ACTAVIS MID ATLANTIC

Marketing Status

Discontinued001

Application Products

001LOTION;TOPICALEQ 0.05% BASE0BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATE

FDA Submissions

ORIG1AP1985-07-31
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1986-10-09
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1987-11-06
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1989-02-15
MANUF (CMC); Manufacturing (CMC)SUPPL7AP1989-02-15
MANUF (CMC); Manufacturing (CMC)SUPPL8AP1989-02-15
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1991-01-23
LABELING; LabelingSUPPL10AP1990-10-09
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1990-09-28
MANUF (CMC); Manufacturing (CMC)SUPPL13AP1992-04-20
LABELING; LabelingSUPPL14AP1991-03-05
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1992-04-06
MANUF (CMC); Manufacturing (CMC)SUPPL16AP1992-07-15
MANUF (CMC); Manufacturing (CMC)SUPPL17AP1994-12-23
LABELING; LabelingSUPPL18AP1995-07-19
LABELING; LabelingSUPPL20AP2003-01-22

Submissions Property Types

SUPPL1Null0
SUPPL3Null0
SUPPL4Null0
SUPPL6Null0
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL12Null0
SUPPL13Null0
SUPPL15Null0
SUPPL16Null0
SUPPL17Null0

TE Codes

001PrescriptionAB

CDER Filings

ACTAVIS MID ATLANTIC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 70281
            [companyName] => ACTAVIS MID ATLANTIC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BETAMETHASONE DIPROPIONATE","activeIngredients":"BETAMETHASONE DIPROPIONATE","strength":"EQ 0.05% BASE","dosageForm":"LOTION;TOPICAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BETAMETHASONE DIPROPIONATE","submission":"BETAMETHASONE DIPROPIONATE","actionType":"EQ 0.05% BASE","submissionClassification":"LOTION;TOPICAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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