Documents
Application Sponsors
NDA 209940 | MERCK SHARP DOHME | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Application Products
001 | SOLUTION;INTRAVENOUS | 240MG/12ML (20MG/ML) | 1 | PREVYMIS | LETERMOVIR |
002 | SOLUTION;INTRAVENOUS | 480MG/24ML (20MG/ML) | 1 | PREVYMIS | LETERMOVIR |
FDA Submissions
TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2017-11-08 | PRIORITY |
LABELING; Labeling | SUPPL | 3 | AP | 2019-08-29 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2019-12-20 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2020-03-23 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 7 |
SUPPL | 3 | Null | 7 |
SUPPL | 4 | Null | 7 |
SUPPL | 6 | Null | 7 |
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
)
)