ANDA 089624

ORGANON USA INC

FDA Drug Application

Application #089624

Application Sponsors

ANDA 089624

ORGANON USA INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

REVERSOL

EDROPHONIUM CHLORIDE

FDA Submissions

	ORIG	1	AP	1988-05-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1992-02-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1992-05-08
LABELING; Labeling	SUPPL	4	AP	1993-11-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-03-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1996-03-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-01-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-06-09

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 89624
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REVERSOL","activeIngredients":"EDROPHONIUM CHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"REVERSOL","submission":"EDROPHONIUM CHLORIDE","actionType":"10MG\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)