ALNYLAM PHARMS INC FDA Approval NDA 215515

NDA 215515

ALNYLAM PHARMS INC

FDA Drug Application

Application #215515

Documents

Label2022-06-14
Letter2022-06-14

Application Sponsors

NDA 215515ALNYLAM PHARMS INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;SUBCUTANEOUS25MG0AMVUTTRAVUTRISIRAN

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-06-13PRIORITY

Submissions Property Types

ORIG1Null2

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
        )

)

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