ALLERGAN FDA Approval NDA 021275

NDA 021275

ALLERGAN

FDA Drug Application

Application #021275

Documents

Letter2003-08-28
Letter2003-11-25
Letter2012-03-19
Label2001-03-16
Label2002-08-26
Label2003-08-28
Label2011-03-11
Label2006-06-28
Label2003-12-02
Label2014-09-30
Letter2004-06-08
Letter2002-08-26
Letter2003-08-28
Letter2006-06-28
Letter2003-11-25
Letter2014-10-02
Label2003-08-28
Label2003-12-02
Label2011-02-08
Label2012-03-16
Review2001-08-20
Review2008-07-30
Label2017-08-01
Letter2017-08-02
Letter2020-10-16
Label2020-10-16
Letter2022-03-09
Label2022-03-11

Application Sponsors

NDA 021275ALLERGAN

Marketing Status

Discontinued001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**1LUMIGANBIMATOPROST

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2001-03-16PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2001-08-07PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2002-04-17PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL5AP2002-04-12PRIORITY
LABELING; LabelingSUPPL6AP2002-08-26STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL10AP2003-08-25PRIORITY
LABELING; LabelingSUPPL11AP2011-03-11STANDARD
LABELING; LabelingSUPPL12AP2003-08-25STANDARD
EFFICACY; EfficacySUPPL13AP2006-06-22UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL14AP2003-11-10PRIORITY
LABELING; LabelingSUPPL15AP2003-11-10STANDARD
LABELING; LabelingSUPPL22AP2011-03-11UNKNOWN
LABELING; LabelingSUPPL23AP2012-03-15UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL24AP2013-02-28PRIORITY
LABELING; LabelingSUPPL26AP2014-09-29STANDARD
LABELING; LabelingSUPPL27AP2017-07-29STANDARD
LABELING; LabelingSUPPL28AP2020-10-15STANDARD
LABELING; LabelingSUPPL29AP2022-03-08STANDARD

Submissions Property Types

SUPPL2Null0
SUPPL3Null0
SUPPL5Null0
SUPPL10Null0
SUPPL11Null6
SUPPL13Null31
SUPPL14Null0
SUPPL22Null7
SUPPL23Null15
SUPPL24Null0
SUPPL26Null7
SUPPL27Null7
SUPPL28Null15
SUPPL29Null6

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21275
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUMIGAN","activeIngredients":"BIMATOPROST","strength":"0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"07\/29\/2017","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021275s027lbl.pdf\"}]","notes":""},{"actionDate":"09\/29\/2014","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021275s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/15\/2012","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021275s023lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2011","submission":"SUPPL-22","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021275s022lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2011","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021275s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2006","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/021275s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2003","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21275scs014,slr015_lumigan_lbl.pdf\"}]","notes":""},{"actionDate":"11\/10\/2003","submission":"SUPPL-14","supplementCategories":"Manufacturing (CMC)-Control","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21275scs014,slr015_lumigan_lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"08\/25\/2003","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21275scp010,slr012_lumigan_lbl.pdf\"}]","notes":""},{"actionDate":"08\/25\/2003","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)-Packaging","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2003\\\/21275scp010,slr012_lumigan_lbl.pdf\"}]","notes":""},{"actionDate":"08\/26\/2002","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21275s6lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/21275lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LUMIGAN","submission":"BIMATOPROST","actionType":"0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-07-29
        )

)
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