MERCK SHARP DOHME FDA Approval NDA 204569

NDA 204569

MERCK SHARP DOHME

FDA Drug Application

Application #204569

Documents

Letter2014-11-12
Letter2016-05-31
Label2014-08-14
Label2014-11-10
Letter2014-08-14
Review2014-09-12
Summary Review2014-09-12
Label2018-07-13
Medication Guide2018-07-13
Letter2018-07-16
Letter2020-02-03
Label2020-01-31
Medication Guide2020-01-31
Label2020-03-20
Medication Guide2020-03-20
Letter2020-03-19
Label2021-03-26
Medication Guide2021-03-26
Letter2021-03-29

Application Sponsors

NDA 204569MERCK SHARP DOHME

Marketing Status

Prescription001
Prescription002
Prescription003
Prescription004

Application Products

001TABLET;ORAL5MG1BELSOMRASUVOREXANT
002TABLET;ORAL10MG1BELSOMRASUVOREXANT
003TABLET;ORAL15MG1BELSOMRASUVOREXANT
004TABLET;ORAL20MG1BELSOMRASUVOREXANT

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2014-08-13STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL2AP2015-04-30STANDARD
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2016-05-03STANDARD
LABELING; LabelingSUPPL4AP2016-05-27STANDARD
LABELING; LabelingSUPPL5AP2018-07-12STANDARD
EFFICACY; EfficacySUPPL6AP2020-01-29STANDARD
LABELING; LabelingSUPPL7AP2020-03-18STANDARD
LABELING; LabelingSUPPL8AP2021-03-25STANDARD

Submissions Property Types

ORIG1Null15
SUPPL2Null0
SUPPL3Null0
SUPPL4Null15
SUPPL5Null6
SUPPL6Null6
SUPPL7Null6
SUPPL8Null7

CDER Filings

MERCK SHARP DOHME
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204569
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/204569Orig1s007lbl.pdf#page=23"]
            [products] => [{"drugName":"BELSOMRA","activeIngredients":"SUVOREXANT","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BELSOMRA","activeIngredients":"SUVOREXANT","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BELSOMRA","activeIngredients":"SUVOREXANT","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"BELSOMRA","activeIngredients":"SUVOREXANT","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/18\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204569Orig1s007lbl.pdf\"}]","notes":""},{"actionDate":"01\/29\/2020","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204569s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/12\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204569s005lbl.pdf\"}]","notes":""},{"actionDate":"11\/07\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204569s001lbl.pdf\"}]","notes":""},{"actionDate":"08\/13\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204569s000lbledt.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/13\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204569s000lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204569Orig1s000rltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204569Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/204569Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/18\/2020","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204569Orig1s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204569Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/29\/2020","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/204569s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/204569Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"07\/12\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/204569s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/204569Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"05\/27\/2016","submission":"SUPPL-4","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/204569Orig1s004ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"05\/03\/2016","submission":"SUPPL-3","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/30\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/07\/2014","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/204569s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/204569Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-03-18
        )

)
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