MSN FDA Approval ANDA 216091

ANDA 216091

MSN

FDA Drug Application

Application #216091

Application Sponsors

ANDA 216091MSN

Marketing Status

Prescription001

Application Products

001POWDER;INTRAMUSCULAREQ 20MG BASE/VIAL0ZIPRASIDONE MESYLATEZIPRASIDONE MESYLATE

FDA Submissions

UNKNOWN; ORIG1AP2022-09-15STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAP

CDER Filings

MSN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216091
            [companyName] => MSN
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZIPRASIDONE MESYLATE","activeIngredients":"ZIPRASIDONE MESYLATE","strength":"EQ 20MG BASE\/VIAL","dosageForm":"POWDER;INTRAMUSCULAR","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/15\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-09-15
        )

)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.