ANDA 211374

AMNEAL

FDA Drug Application

Application #211374

Application Sponsors

ANDA 211374

AMNEAL

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/VIAL

0

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-03-05	STANDARD
REMS; REMS	SUPPL	2	AP	2021-08-11
LABELING; Labeling	SUPPL	5	AP	2022-12-23	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-12-23	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	5	Null	7
SUPPL	6	Null	7

TE Codes

001

Prescription

AP

CDER Filings

AMNEAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211374
            [companyName] => AMNEAL
            [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":"03\/05\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-03-05
        )

)