ALLERGAN FDA Approval NDA 022117

NDA 022117

ALLERGAN

FDA Drug Application

Application #022117

Documents

Letter2009-08-26
Letter2010-09-21
Letter2010-12-07
Letter2011-08-11
Letter2014-10-23
Letter2014-11-19
Letter2015-03-13
Label2009-08-26
Label2010-08-30
Label2010-12-04
Label2014-10-24
Label2013-03-26
Label2012-11-08
Label2014-11-20
Label2014-11-20
Label2015-03-17
Review2009-10-02
Summary Review2009-10-02
Letter2010-09-21
Letter2011-10-13
Letter2013-03-22
Letter2012-11-09
Letter2014-11-19
Letter2014-11-19
Letter2015-03-13
Letter2015-03-13
Label2010-08-30
Label2011-10-12
Label2011-08-11
Label2014-11-20
Label2015-03-17
Label2015-03-17
Other Important Information from FDA2011-12-20
Label2017-01-13
Label2017-01-13
Letter2017-01-24
Letter2017-01-24
Label2017-02-24
Letter2017-03-02
Pediatric Written Request2009-09-23
Pediatric Written Request2009-09-23
Pediatric Amendment 12010-06-02
Pediatric Amendment 12010-06-02
Pediatric Amendment 22010-10-22
Pediatric Amendment 22010-10-22
Pediatric Amendment 32013-08-30
Pediatric Amendment 32013-08-30
Pediatric Amendment 42014-02-06
Pediatric Amendment 42014-02-06
Pediatric Medical Review1900-01-01
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Statistical Review1900-01-01

Application Sponsors

NDA 022117ALLERGAN

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;SUBLINGUALEQ 5MG BASE1SAPHRISASENAPINE MALEATE
002TABLET;SUBLINGUALEQ 10MG BASE1SAPHRISASENAPINE MALEATE
003TABLET;SUBLINGUALEQ 2.5MG BASE1SAPHRISASENAPINE MALEATE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2009-08-13STANDARD
EFFICACY; EfficacySUPPL3AP2010-09-03STANDARD
EFFICACY; EfficacySUPPL4AP2010-09-03STANDARD
LABELING; LabelingSUPPL7AP2010-12-01901 REQUIRED
LABELING; LabelingSUPPL9AP2011-10-11STANDARD
LABELING; LabelingSUPPL10AP2011-08-09901 REQUIRED
LABELING; LabelingSUPPL11AP2014-10-21STANDARD
LABELING; LabelingSUPPL12AP2013-03-21STANDARD
LABELING; LabelingSUPPL13AP2012-11-08STANDARD
LABELING; LabelingSUPPL14AP2014-11-18STANDARD
LABELING; LabelingSUPPL15AP2014-11-18STANDARD
LABELING; LabelingSUPPL16AP2014-11-18STANDARD
LABELING; LabelingSUPPL17AP2015-03-12STANDARD
EFFICACY; EfficacySUPPL18AP2015-03-12PRIORITY
EFFICACY; EfficacySUPPL19AP2015-03-12PRIORITY
EFFICACY; EfficacySUPPL20AP2017-01-13STANDARD
EFFICACY; EfficacySUPPL21AP2017-01-13STANDARD
LABELING; LabelingSUPPL22AP2017-02-23901 REQUIRED

Submissions Property Types

ORIG1Null6
SUPPL3Null7
SUPPL4Null31
SUPPL7Null7
SUPPL9Null7
SUPPL10Null7
SUPPL11Null7
SUPPL12Null15
SUPPL13Null6
SUPPL14Null6
SUPPL15Null7
SUPPL16Null7
SUPPL17Null15
SUPPL18Null6
SUPPL19Null6
SUPPL20Null7
SUPPL21Null7
SUPPL22Null15

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

ALLERGAN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22117
            [companyName] => ALLERGAN
            [docInserts] => ["",""]
            [products] => [{"drugName":"SAPHRIS","activeIngredients":"ASENAPINE MALEATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"SAPHRIS","activeIngredients":"ASENAPINE MALEATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"SAPHRIS","activeIngredients":"ASENAPINE MALEATE","strength":"EQ 2.5MG BASE","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"02\/23\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022117s022lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2017","submission":"SUPPL-21","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022117s020s021lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2017","submission":"SUPPL-20","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/022117s020s021lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2015","submission":"SUPPL-19","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022117s017s018s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2015","submission":"SUPPL-18","supplementCategories":"Efficacy-Pediatric","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022117s017s018s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/12\/2015","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/022117s017s018s019lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2014","submission":"SUPPL-16","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022117s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2014","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022117s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2014","submission":"SUPPL-14","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022117s014s015s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2014","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/022117s011lbl.pdf\"}]","notes":""},{"actionDate":"03\/21\/2013","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/022117s012lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2012","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/022117s013lbl.pdf\"}]","notes":""},{"actionDate":"10\/11\/2011","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022117s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/09\/2011","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/022117s010lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2010","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022117s007lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2010","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022117s003s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/03\/2010","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/022117s003s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2009","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/022117s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"SAPHRIS","submission":"ASENAPINE MALEATE","actionType":"EQ 5MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SAPHRIS","submission":"ASENAPINE MALEATE","actionType":"EQ 10MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"SAPHRIS","submission":"ASENAPINE MALEATE","actionType":"EQ 2.5MG BASE","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-02-23
        )

)
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