AKORN FDA Approval ANDA 090726

ANDA 090726

AKORN

FDA Drug Application

Application #090726

Application Sponsors

ANDA 090726AKORN

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION40MG/2ML (20MG/ML)0IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE
002INJECTABLE;INJECTION100MG/5ML (20MG/ML)0IRINOTECAN HYDROCHLORIDEIRINOTECAN HYDROCHLORIDE

FDA Submissions

ORIG1AP2009-09-16

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

AKORN
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90726
            [companyName] => AKORN
            [docInserts] => ["",""]
            [products] => [{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"40MG\/2ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"IRINOTECAN HYDROCHLORIDE","activeIngredients":"IRINOTECAN HYDROCHLORIDE","strength":"100MG\/5ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"IRINOTECAN HYDROCHLORIDE","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"40MG\/2ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"IRINOTECAN HYDROCHLORIDE","submission":"IRINOTECAN HYDROCHLORIDE","actionType":"100MG\/5ML (20MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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