NDA 214375

POLAREAN INC

FDA Drug Application

Application #214375

Documents

• Label: 2022-12-23
• Letter: 2022-12-27
• Review: 2023-01-24

Application Sponsors

NDA 214375

POLAREAN INC

Marketing Status

• Prescription: 001

Application Products

001

INHALANT;ORAL

1000ML

0

XENOVIEW

XENON XE 129 HYPERPOLARIZED

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2022-12-23

STANDARD

Submissions Property Types

ORIG

1

Null

6

CDER Filings

POLAREAN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214375
            [companyName] => POLAREAN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"XENOVIEW","activeIngredients":"XENON XE 129 HYPERPOLARIZED","strength":"1000ML","dosageForm":"INHALANT;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/23\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214375s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/23\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/214375s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/214375Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-12-23
        )

)