SUNOVION PHARMS INC FDA Approval NDA 021476

NDA 021476

SUNOVION PHARMS INC

FDA Drug Application

Application #021476

Documents

Letter2004-12-30
Letter2008-01-30
Letter2008-01-30
Letter2009-04-10
Letter2012-01-31
Letter2012-10-12
Letter2012-10-12
Letter2014-02-10
Letter2014-05-20
Label2004-12-30
Label2008-01-30
Label2009-04-16
Label2012-10-12
Label2012-10-12
Label2014-02-06
Label2008-01-30
Label2014-05-16
Review2005-04-27
Medication Guide2009-11-19
Other Important Information from FDA2007-03-16
Pediatric Written Request2006-08-02
Pediatric Amendment 12010-04-13
Pediatric Medical Review1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Label2018-11-08
Letter2018-11-15
Label2019-02-07
Letter2019-02-14
Letter2020-02-03
Label2020-02-04
Medication Guide2020-02-04

Application Sponsors

NDA 021476SUNOVION PHARMS INC

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001TABLET;ORAL1MG1LUNESTAESZOPICLONE
002TABLET;ORAL2MG1LUNESTAESZOPICLONE
003TABLET;ORAL3MG1LUNESTAESZOPICLONE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2004-12-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL4AP2006-05-23N/A
LABELING; LabelingSUPPL5AP2008-01-29STANDARD
LABELING; LabelingSUPPL8AP2008-01-29STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL11AP2009-04-23N/A
MANUF (CMC); Manufacturing (CMC)SUPPL12AP2009-04-06N/A
LABELING; LabelingSUPPL15AP2009-09-30STANDARD
LABELING; LabelingSUPPL21AP2012-01-26UNKNOWN
LABELING; LabelingSUPPL24AP2012-10-10UNKNOWN
MANUF (CMC); Manufacturing (CMC)SUPPL25AP2014-04-04STANDARD
EFFICACY; EfficacySUPPL26AP2012-10-10PRIORITY
MANUF (CMC); Manufacturing (CMC)SUPPL27AP2015-02-16STANDARD
LABELING; LabelingSUPPL28AP2014-02-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL29AP2014-05-29STANDARD
LABELING; LabelingSUPPL30AP2014-05-15STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL31AP2014-11-03STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL32AP2015-08-27STANDARD
LABELING; LabelingSUPPL36AP2018-11-07STANDARD
LABELING; LabelingSUPPL37AP2019-02-06901 REQUIRED
LABELING; LabelingSUPPL38AP2019-08-18901 REQUIRED

Submissions Property Types

SUPPL21Null6
SUPPL24Null7
SUPPL25Null0
SUPPL26Null6
SUPPL27Null0
SUPPL28Null15
SUPPL29Null0
SUPPL30Null6
SUPPL31Null0
SUPPL32Null0
SUPPL36Null15
SUPPL37Null6
SUPPL38Null6

TE Codes

001PrescriptionAB
002PrescriptionAB
003PrescriptionAB

CDER Filings

SUNOVION PHARMS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21476
            [companyName] => SUNOVION PHARMS INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/021476Orig1s038rplLBL.pdf#page=26"]
            [products] => [{"drugName":"LUNESTA","activeIngredients":"ESZOPICLONE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LUNESTA","activeIngredients":"ESZOPICLONE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"LUNESTA","activeIngredients":"ESZOPICLONE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/18\/2019","submission":"SUPPL-38","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021476Orig1s038rplLBL.pdf\"}]","notes":""},{"actionDate":"02\/06\/2019","submission":"SUPPL-37","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/021476s037lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2018","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/021476s036lbl.pdf\"}]","notes":""},{"actionDate":"05\/15\/2014","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021476s030lbl.pdf\"}]","notes":""},{"actionDate":"02\/03\/2014","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/021476s028lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2012","submission":"SUPPL-26","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021476s024s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2012","submission":"SUPPL-24","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021476s024s026lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2012","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/021476s024s026lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2009","submission":"SUPPL-12","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021476s012lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2008","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021476s005s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2008","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021476s005s008lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/021476lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LUNESTA","submission":"ESZOPICLONE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LUNESTA","submission":"ESZOPICLONE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"LUNESTA","submission":"ESZOPICLONE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-08-18
        )

)
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