ANDA 203859

MYLAN LABS LTD

FDA Drug Application

Application #203859

Application Sponsors

ANDA 203859

MYLAN LABS LTD

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

500MG/VIAL

0

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

FDA Submissions

UNKNOWN;	ORIG	1	AP	2017-03-31
REMS; REMS	SUPPL	3	AP	2021-01-15
REMS; REMS	SUPPL	7	AP	2021-04-21
REMS; REMS	SUPPL	9	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	15
SUPPL	3	Null	7
SUPPL	7	Null	15
SUPPL	9	Null	15

TE Codes

001

Prescription

AP

CDER Filings

MYLAN LABS LTD

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    [0] => Array
        (
            [ApplNo] => 203859
            [companyName] => MYLAN LABS LTD
            [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\/31\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-03-31
        )

)