NDA 019677

MYLAN INSTITUTIONAL

FDA Drug Application

Application #019677

Documents

• Letter: 2005-12-15
• Label: 2005-12-15
• Label: 2009-04-03
• Letter: 2009-04-03

Application Sponsors

NDA 019677

MYLAN INSTITUTIONAL

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.14MG/ML;10MG/ML

0

ENLON-PLUS

ATROPINE SULFATE; EDROPHONIUM CHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	1991-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2000-12-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2002-04-18	STANDARD
LABELING; Labeling	SUPPL	5	AP	2005-12-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2009-04-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0

CDER Filings

MYLAN INSTITUTIONAL

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19677
            [companyName] => MYLAN INSTITUTIONAL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ENLON-PLUS","activeIngredients":"ATROPINE SULFATE; EDROPHONIUM CHLORIDE","strength":"0.14MG\/ML;10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/01\/2009","submission":"SUPPL-6","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019677s006lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"12\/06\/2005","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/019677s005,019678s005lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ENLON-PLUS","submission":"ATROPINE SULFATE; EDROPHONIUM CHLORIDE","actionType":"0.14MG\/ML;10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2009-04-01
        )

)