AMYLYX PHARMS FDA Approval NDA 216660

NDA 216660

AMYLYX PHARMS

FDA Drug Application

Application #216660

Documents

Summary Review2022-09-29
Letter2022-09-29
Label2022-09-29
Review2022-10-27

Application Sponsors

NDA 216660AMYLYX PHARMS

Marketing Status

Prescription001

Application Products

001SUSPENSION; ORAL3G/1G2RELYVRIOSODIUM PHENYLBUTYRATE; SODIUM TAURURSODIOL

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2022-09-29PRIORITY

Submissions Property Types

ORIG1Null6

CDER Filings

AMYLYX PHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216660
            [companyName] => AMYLYX PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"RELYVRIO","activeIngredients":"SODIUM PHENYLBUTYRATE; SODIUM TAURURSODIOL","strength":"3G\/1G","dosageForm":"SUSPENSION; ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"09\/29\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216660s000lbledt.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/29\/2022","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\\\/2022\\\/216660s000lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216660Orig1s000ltr.pdf\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2022\\\/216660Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-09-29
        )

)

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