ANDA 090419

APOTEX CORP

FDA Drug Application

Application #090419

Documents

• Other: 2015-07-06
• Other Important Information from FDA: 2009-07-15

Application Sponsors

ANDA 090419

APOTEX CORP

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

250MG

0

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL

FDA Submissions

	ORIG	1	AP	2009-04-22
LABELING; Labeling	SUPPL	2	AP	2010-04-15
LABELING; Labeling	SUPPL	3	AP	2010-04-16
REMS; REMS	SUPPL	4	AP	2012-09-25
LABELING; Labeling	SUPPL	5	AP	2012-08-31	STANDARD
LABELING; Labeling	SUPPL	7	AP	2013-09-27	STANDARD
LABELING; Labeling	SUPPL	8	AP	2015-10-06	STANDARD
REMS; REMS	SUPPL	9	AP	2015-11-13
LABELING; Labeling	SUPPL	10	AP	2015-10-06	STANDARD

Submissions Property Types

SUPPL	2	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	15

CDER Filings

APOTEX CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90419
            [companyName] => APOTEX CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOPHENOLATE MOFETIL","submission":"MYCOPHENOLATE MOFETIL","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)