ALLERGAN FDA Approval NDA 021398

NDA 021398

ALLERGAN

FDA Drug Application

Application #021398

Documents

Letter2012-10-15
Label2012-10-12
Summary Review2008-07-22
Letter2007-11-08
Letter2015-10-16
Label2015-10-22
Review2008-04-22
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01

Application Sponsors

NDA 021398ALLERGAN

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.2%;EQ 0.5% BASE1COMBIGANBRIMONIDINE TARTRATE; TIMOLOL MALEATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2007-10-30STANDARD
LABELING; LabelingSUPPL6AP2012-10-11STANDARD
LABELING; LabelingSUPPL7AP2015-10-15STANDARD

Submissions Property Types

ORIG1Null31
SUPPL6Null7
SUPPL7Null15

TE Codes

001PrescriptionAT

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21398
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"COMBIGAN","activeIngredients":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","strength":"0.2%;EQ 0.5% BASE","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/15\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021398s007lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2012","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021398s006lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"COMBIGAN","submission":"BRIMONIDINE TARTRATE; TIMOLOL MALEATE","actionType":"0.2%;EQ 0.5% BASE","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2015-10-15
        )

)

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