ANDA 204043

AKORN INC

FDA Drug Application

Application #204043

Documents

• REMS: 2017-03-03

Application Sponsors

ANDA 204043

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/VIAL

0

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-02-28
LABELING; Labeling	SUPPL	3	AP	2019-11-27	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-11-27	STANDARD
REMS; REMS	SUPPL	8	AP	2021-01-15
REMS; REMS	SUPPL	9	AP	2021-04-21
REMS; REMS	SUPPL	11	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	11	Null	7

TE Codes

001

Prescription

AP

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
        )

)