NEPHRON FDA Approval ANDA 211222

ANDA 211222

NEPHRON

FDA Drug Application

Application #211222

Application Sponsors

ANDA 211222NEPHRON

Marketing Status

Prescription001

Application Products

001LIQUID;N/A100% (5ML)0STERILE WATER FOR INJECTIONSTERILE WATER FOR INJECTION

FDA Submissions

UNKNOWN; ORIG1AP2021-02-10STANDARD

Submissions Property Types

ORIG1Null15

CDER Filings

NEPHRON
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211222
            [companyName] => NEPHRON
            [docInserts] => ["",""]
            [products] => [{"drugName":"STERILE WATER FOR INJECTION","activeIngredients":"STERILE WATER FOR INJECTION","strength":"100% (5ML)","dosageForm":"LIQUID;N\/A","marketingStatus":"Prescription","te":"None","rld":"No","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/10\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-02-10
        )

)

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