NDA 213687

ULTRAGENYX PHARM INC

FDA Drug Application

Application #213687

Documents

• Label: 2020-06-30
• Letter: 2020-07-01
• Review: 2020-07-29

Application Sponsors

NDA 213687

ULTRAGENYX PHARM INC

Marketing Status

• Prescription: 001

Application Products

001

LIQUID;ORAL

35%

2

DOJOLVI

TRIHEPTANOIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-06-30

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

ULTRAGENYX PHARM INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213687
            [companyName] => ULTRAGENYX PHARM INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOJOLVI","activeIngredients":"TRIHEPTANOIN","strength":"35%","dosageForm":"LIQUID;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/30\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213687s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/30\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213687s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213687Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-06-30
        )

)