ALLERGAN FDA Approval NDA 020490

NDA 020490

ALLERGAN

FDA Drug Application

Application #020490

Documents

Letter2016-03-25
Label2001-12-20
Letter2001-12-20
Label2016-03-28
Review2004-05-27

Application Sponsors

NDA 020490ALLERGAN

Marketing Status

Discontinued001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.5%0ALPHAGANBRIMONIDINE TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP1997-03-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1998-02-25STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1998-05-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1999-08-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2000-05-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL6AP2001-04-09STANDARD
EFFICACY; EfficacySUPPL7AP2001-12-20STANDARD
LABELING; LabelingSUPPL8AP2016-03-23STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null0
SUPPL7Null6
SUPPL8Null7

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20490
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPHAGAN","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.5%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/23\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/020490s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2001","submission":"SUPPL-7","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21262s6lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALPHAGAN","submission":"BRIMONIDINE TARTRATE","actionType":"0.5%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2016-03-23
        )

)

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