ANDA 088873

MYLAN INSTITUTIONAL

FDA Drug Application

Application #088873

Application Sponsors

ANDA 088873

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

ENLON

EDROPHONIUM CHLORIDE

FDA Submissions

	ORIG	1	AP	1985-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1986-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-09-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1991-02-07
LABELING; Labeling	SUPPL	12	AP	1991-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2000-07-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-02-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2001-02-20
LABELING; Labeling	SUPPL	19	AP	2009-04-03
LABELING; Labeling	SUPPL	22	AP	2009-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	2011-01-10

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	22	Null	7
SUPPL	23	Null	1

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 88873
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENLON","activeIngredients":"EDROPHONIUM CHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ENLON","submission":"EDROPHONIUM CHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)