NDA 213895

XELLIA PHARMS APS

FDA Drug Application

Application #213895

Documents

• Letter: 2021-08-30
• Label: 2021-09-20
• Review: 2022-02-25

Application Sponsors

NDA 213895

XELLIA PHARMS APS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

5G/100ML

2

VANCOMYCIN

VANCOMYCIN

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2021-08-26

PRIORITY

Submissions Property Types

ORIG

1

Null

2

TE Codes

001

Prescription

TBD

CDER Filings

XELLIA PHARMS APS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213895
            [companyName] => XELLIA PHARMS APS
            [docInserts] => ["",""]
            [products] => [{"drugName":"VANCOMYCIN","activeIngredients":"VANCOMYCIN","strength":"5G\/100ML","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/26\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213895Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-08-26
        )

)