NDA 019638

ORGANON USA INC

FDA Drug Application

Application #019638

Documents

• Letter: 2010-11-30

Application Sponsors

NDA 019638

ORGANON USA INC

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/VIAL

0

ARDUAN

PIPECURONIUM BROMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1990-06-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-03-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-02-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-05-05	STANDARD
LABELING; Labeling	SUPPL	5	AP	2010-11-22	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19638
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ARDUAN","activeIngredients":"PIPECURONIUM BROMIDE","strength":"10MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ARDUAN","submission":"PIPECURONIUM BROMIDE","actionType":"10MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)