ANDA 214871

AMNEAL

FDA Drug Application

Application #214871

Application Sponsors

ANDA 214871

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;ORAL

200MG/ML

0

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-11-02	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-12-21	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214871
            [companyName] => AMNEAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"200MG\/ML","dosageForm":"SUSPENSION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/02\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-11-02
        )

)