ANDA 090661

JUBILANT CADISTA

FDA Drug Application

Application #090661

Documents

• Other: 2015-07-06

Application Sponsors

ANDA 090661

JUBILANT CADISTA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

500MG

0

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL

FDA Submissions

	ORIG	1	AP	2014-12-15
REMS; REMS	SUPPL	2	AP	2015-11-13
LABELING; Labeling	SUPPL	3	AP	2016-07-27	STANDARD
REMS; REMS	SUPPL	6	AP	2021-01-15
REMS; REMS	SUPPL	9	AP	2021-04-21
REMS; REMS	SUPPL	10	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	17
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	6	Null	15
SUPPL	9	Null	7
SUPPL	10	Null	7

CDER Filings

JUBILANT CADISTA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90661
            [companyName] => JUBILANT CADISTA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOPHENOLATE MOFETIL","submission":"MYCOPHENOLATE MOFETIL","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)