MERCK SHARP DOHME FDA Approval NDA 209940

NDA 209940

MERCK SHARP DOHME

FDA Drug Application

Application #209940

Documents

Label2017-11-08
Letter2017-11-08
Review2017-12-18
Letter2019-03-07
Label2019-03-07
Label2019-08-30
Letter2019-09-03
Label2019-12-23
Letter2019-12-26
Label2020-03-24
Letter2020-03-24

Application Sponsors

NDA 209940MERCK SHARP DOHME

Marketing Status

Prescription001
Prescription002

Application Products

001SOLUTION;INTRAVENOUS240MG/12ML (20MG/ML)1PREVYMISLETERMOVIR
002SOLUTION;INTRAVENOUS480MG/24ML (20MG/ML)1PREVYMISLETERMOVIR

FDA Submissions

TYPE 3; Type 3 - New Dosage FormORIG1AP2017-11-08PRIORITY
LABELING; LabelingSUPPL3AP2019-08-29STANDARD
LABELING; LabelingSUPPL4AP2019-12-20STANDARD
LABELING; LabelingSUPPL6AP2020-03-23STANDARD

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL4Null7
SUPPL6Null7

CDER Filings

MERCK SHARP DOHME
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209940
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREVYMIS","activeIngredients":"LETERMOVIR","strength":"240MG\/12ML (20MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"PREVYMIS","activeIngredients":"LETERMOVIR","strength":"480MG\/24ML (20MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/23\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209939s008,209940s006lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209939s006,209940s004lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209939s005,209940s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209939s005,209940s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/05\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209939s003,209940s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209939Orig1s000,209940Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/08\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209939Orig1s000,209940Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209939Orig1s000209940Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209939Orig1s000,209940Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/23\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209939s008,209940s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"12\/20\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209939s006,209940s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"08\/29\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209939s005,209940s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"03\/05\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209939s003,209940s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209939Orig1s003,209940Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-03-23
        )

)

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