ANDA 203575

PAR STERILE PRODUCTS

FDA Drug Application

Application #203575

Documents

• Letter: 2016-11-02

Application Sponsors

ANDA 203575

PAR STERILE PRODUCTS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/VIAL

0

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-10-28
LABELING; Labeling	SUPPL	3	AP	2021-10-15	STANDARD
REMS; REMS	SUPPL	4	AP	2021-01-15
REMS; REMS	SUPPL	6	AP	2021-04-21
REMS; REMS	SUPPL	7	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	42
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	7

TE Codes

001

Prescription

AP

CDER Filings

PAR STERILE PRODUCTS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203575
            [companyName] => PAR STERILE PRODUCTS
            [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":"10\/28\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/203575Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-10-28
        )

)