NDA 018450

ABBVIE

FDA Drug Application

Application #018450

Application Sponsors

NDA 018450

ABBVIE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

NITROPRESS

SODIUM NITROPRUSSIDE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1981-09-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1984-01-23	STANDARD
LABELING; Labeling	SUPPL	3	AP	1984-12-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1984-10-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-09-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-02-20	STANDARD
LABELING; Labeling	SUPPL	9	AP	1990-09-21	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	9	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18450
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NITROPRESS","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"50MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NITROPRESS","submission":"SODIUM NITROPRUSSIDE","actionType":"50MG\/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)