NDA 214662

MIRUM PHARMA INC

FDA Drug Application

Application #214662

Documents

• Label: 2021-09-29
• Letter: 2021-09-30
• Letter: 2021-10-21
• Review: 2021-12-10
• Letter: 2022-04-04
• Label: 2022-04-05

Application Sponsors

NDA 214662

MIRUM PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

9.5MG

0

LIVMARLI

MARALIXIBAT CHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2021-09-29

PRIORITY

Submissions Property Types

ORIG

1

Null

7

CDER Filings

MIRUM PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214662
            [companyName] => MIRUM PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIVMARLI","activeIngredients":"MARALIXIBAT CHLORIDE","strength":"9.5MG","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/29\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214662s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/29\/2021","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\\\/2021\\\/214662s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214662Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-09-29
        )

)