AKORN INC FDA Approval ANDA 204043

ANDA 204043

AKORN INC

FDA Drug Application

Application #204043

Documents

REMS2017-03-03

Application Sponsors

ANDA 204043AKORN INC

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION500MG/VIAL0MYCOPHENOLATE MOFETIL HYDROCHLORIDEMYCOPHENOLATE MOFETIL HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2017-02-28
LABELING; LabelingSUPPL3AP2019-11-27STANDARD
LABELING; LabelingSUPPL4AP2019-11-27STANDARD
REMS; REMSSUPPL8AP2021-01-15
REMS; REMSSUPPL9AP2021-04-21
REMS; REMSSUPPL11AP2021-08-11

Submissions Property Types

ORIG1Null7
SUPPL3Null7
SUPPL4Null7
SUPPL8Null7
SUPPL9Null7
SUPPL11Null7

TE Codes

001PrescriptionAP

CDER Filings

AKORN INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204043
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL HYDROCHLORIDE","activeIngredients":"MYCOPHENOLATE MOFETIL HYDROCHLORIDE","strength":"500MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"11\/27\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/27\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/27\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-11-27
        )

)

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