Documents
Application Sponsors
NDA 215515 | ALNYLAM PHARMS INC | |
Marketing Status
Application Products
001 | INJECTABLE;SUBCUTANEOUS | 25MG | 0 | AMVUTTRA | VUTRISIRAN |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2022-06-13 | PRIORITY |
Submissions Property Types
CDER Filings
ALNYLAM PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 215515
[companyName] => ALNYLAM PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMVUTTRA","activeIngredients":"VUTRISIRAN","strength":"25MG","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/13\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215515s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/13\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215515s000lbl.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2022-06-13
)
)