ALLERGAN FDA Approval NDA 021262

NDA 021262

ALLERGAN

FDA Drug Application

Application #021262

Documents

Letter2004-02-27
Label2001-12-20
Label2006-05-24
Label2010-08-28
Letter2001-03-16
Letter2001-12-20
Letter2004-02-27
Letter2006-05-25
Letter2010-08-16
Label2001-03-16
Review2004-05-27
Review2004-05-27

Application Sponsors

NDA 021262ALLERGAN

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.15%1ALPHAGAN PBRIMONIDINE TARTRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2001-03-16STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-06-05STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2001-10-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2001-12-18STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2001-12-04STANDARD
EFFICACY; EfficacySUPPL6AP2001-12-20STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL7AP2002-01-22STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL8AP2002-06-19STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL9AP2002-04-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2004-02-10STANDARD
LABELING; LabelingSUPPL13AP2004-02-10STANDARD
LABELING; LabelingSUPPL18AP2006-05-22STANDARD
LABELING; LabelingSUPPL20AP2010-08-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2014-05-19STANDARD

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL5Null0
SUPPL6Null6
SUPPL7Null0
SUPPL8Null0
SUPPL9Null0
SUPPL10Null0
SUPPL20Null6
SUPPL24Null0

TE Codes

001PrescriptionAT

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21262
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ALPHAGAN P","activeIngredients":"BRIMONIDINE TARTRATE","strength":"0.15%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/13\/2010","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/021262s020,021770s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2006","submission":"SUPPL-18","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021262s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2001","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21262s6lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2001\\\/21-262_Alphagan%20P%20Ophthalmic_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ALPHAGAN P","submission":"BRIMONIDINE TARTRATE","actionType":"0.15%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2010-08-13
        )

)

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