ALLERGAN FDA Approval NDA 022134

NDA 022134

ALLERGAN

FDA Drug Application

Application #022134

Documents

Letter2015-10-02
Label2015-10-07
Review2010-08-23
Summary Review2011-02-17
Letter2010-07-30
Letter2014-12-05
Label2010-07-31
Label2014-12-10
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Letter2020-06-10
Label2020-06-12
Label2021-12-13
Letter2021-12-15
Letter2022-08-30

Application Sponsors

NDA 022134ALLERGAN

Marketing Status

Prescription001

Application Products

001SOLUTION/DROPS;OPHTHALMIC0.25%1LASTACAFTALCAFTADINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2010-07-28STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2014-08-12STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2014-07-25STANDARD
LABELING; LabelingSUPPL4AP2015-09-30STANDARD
LABELING; LabelingSUPPL7AP2020-06-09STANDARD
EFFICACY; EfficacySUPPL8AP2021-12-10STANDARD
LABELING; LabelingSUPPL9AP2022-08-29STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null0
SUPPL3Null0
SUPPL4Null15
SUPPL7Null7
SUPPL8Null7
SUPPL9Null7

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22134
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LASTACAFT","activeIngredients":"ALCAFTADINE","strength":"0.25%","dosageForm":"SOLUTION\/DROPS;OPHTHALMIC","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/09\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/022134s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022134s004lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022134s001lbl.pdf\"}]","notes":""},{"actionDate":"07\/28\/2010","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022134s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LASTACAFT","submission":"ALCAFTADINE","actionType":"0.25%","submissionClassification":"SOLUTION\/DROPS;OPHTHALMIC","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2020-06-09
        )

)

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