SANDOZ INC FDA Approval ANDA 206604

ANDA 206604

SANDOZ INC

FDA Drug Application

Application #206604

Documents

Letter2021-02-02

Application Sponsors

ANDA 206604SANDOZ INC

Marketing Status

Prescription001

Application Products

001UNKNOWNUNKNOWN0FERUMOXYTOLFERUMOXYTOL

FDA Submissions

UNKNOWN; ORIG1AP2021-01-15STANDARD

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206604
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FERUMOXYTOL","activeIngredients":"FERUMOXYTOL","strength":"EQ 510MG IRON\/17ML (EQ 30MG IRON\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-15
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.