Documents
Application Sponsors
Marketing Status
Application Products
001 | SUSPENSION; ORAL | 3G/1G | 2 | RELYVRIO | SODIUM PHENYLBUTYRATE; SODIUM TAURURSODIOL |
FDA Submissions
TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2022-09-29 | PRIORITY |
Submissions Property Types
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
)
)