ANDA 212130

NANJING KING-FRIEND

FDA Drug Application

Application #212130

Application Sponsors

ANDA 212130

NANJING KING-FRIEND

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/VIAL

0

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2021-01-15	STANDARD
REMS; REMS	SUPPL	2	AP	2021-04-21
REMS; REMS	SUPPL	3	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	7

TE Codes

001

Prescription

AP

CDER Filings

NANJING KING-FRIEND

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212130
            [companyName] => NANJING KING-FRIEND
            [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":"01\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-01-15
        )

)