NDA 019946

ABBVIE

FDA Drug Application

Application #019946

Documents

• Letter: 2010-11-30
• Label: 2010-11-22

Application Sponsors

NDA 019946

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

EQ 1MG BASE/ML

0

NUROMAX

DOXACURIUM CHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1991-03-07	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	1994-12-08	STANDARD
LABELING; Labeling	SUPPL	4	AP	2000-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-12-05	STANDARD
LABELING; Labeling	SUPPL	6	AP	2000-05-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2010-11-22	STANDARD

Submissions Property Types

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

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19946
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NUROMAX","activeIngredients":"DOXACURIUM CHLORIDE","strength":"EQ 1MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/22\/2010","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/019946s007lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NUROMAX","submission":"DOXACURIUM CHLORIDE","actionType":"EQ 1MG BASE\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2010-11-22
        )

)