NDA 209939

MERCK SHARP DOHME

FDA Drug Application

Application #209939

Documents

• Letter: 2020-04-17
• Label: 2017-11-08
• Review: 2017-12-18
• Letter: 2019-03-07
• Label: 2019-03-07
• Label: 2019-08-30
• Letter: 2019-09-03
• Label: 2019-12-23
• Letter: 2019-12-26
• Label: 2020-03-24
• Letter: 2020-03-24

Application Sponsors

NDA 209939

MERCK SHARP DOHME

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	240MG	1	PREVYMIS	LETERMOVIR
002	TABLET;ORAL	480MG	1	PREVYMIS	LETERMOVIR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-11-08	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2019-03-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-08-29	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-12-20	STANDARD
LABELING; Labeling	SUPPL	8	AP	2020-03-23	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	3	Null	6
SUPPL	5	Null	6
SUPPL	6	Null	6
SUPPL	8	Null	7

CDER Filings

MERCK SHARP DOHME

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209939
            [companyName] => MERCK SHARP DOHME
            [docInserts] => ["",""]
            [products] => [{"drugName":"PREVYMIS","activeIngredients":"LETERMOVIR","strength":"240MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PREVYMIS","activeIngredients":"LETERMOVIR","strength":"480MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"03\/23\/2020","submission":"SUPPL-8","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-6","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-5","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-5","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-3","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 1 - New Molecular Entity","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\\\/209939Orig1s000,209940Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209939Orig1s000,209940Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/23\/2020","submission":"SUPPL-8","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-6","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-5","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-3","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
        )

)