NDA 020984

ORGANON USA INC

FDA Drug Application

Application #020984

Documents

• Letter: 1999-08-18
• Label: 1999-08-18
• Label: 2010-11-22
• Review: 2001-07-02
• Letter: 2010-11-30

Application Sponsors

NDA 020984

ORGANON USA INC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	100MG/VIAL	0	RAPLON	RAPACURONIUM BROMIDE
002	INJECTABLE;INJECTION	200MG/VIAL	0	RAPLON	RAPACURONIUM BROMIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1999-08-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-07-07	STANDARD
LABELING; Labeling	SUPPL	3	AP	2010-11-22	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

CDER Filings

ORGANON USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20984
            [companyName] => ORGANON USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"RAPLON","activeIngredients":"RAPACURONIUM BROMIDE","strength":"100MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"RAPLON","activeIngredients":"RAPACURONIUM BROMIDE","strength":"200MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/22\/2010","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/020984s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1999\\\/20984lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"RAPLON","submission":"RAPACURONIUM BROMIDE","actionType":"100MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"RAPLON","submission":"RAPACURONIUM BROMIDE","actionType":"200MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-11-22
        )

)