NDA 017546

ROCHE

FDA Drug Application

Application #017546

Application Sponsors

NDA 017546

ROCHE

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

50MG/VIAL

0

NIPRIDE

SODIUM NITROPRUSSIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1974-05-10	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1977-12-27
LABELING; Labeling	SUPPL	9	AP	1979-01-23
LABELING; Labeling	SUPPL	10	AP	1981-02-13
LABELING; Labeling	SUPPL	12	AP	1985-05-15
LABELING; Labeling	SUPPL	18	AP	1984-07-30
LABELING; Labeling	SUPPL	21	AP	1987-05-27
LABELING; Labeling	SUPPL	23	AP	1990-10-18

CDER Filings

ROCHE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17546
            [companyName] => ROCHE
            [docInserts] => ["",""]
            [products] => [{"drugName":"NIPRIDE","activeIngredients":"SODIUM NITROPRUSSIDE","strength":"50MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NIPRIDE","submission":"SODIUM NITROPRUSSIDE","actionType":"50MG\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)