NDA 013319

MALLINCKRODT

FDA Drug Application

Application #013319

Application Sponsors

NDA 013319

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

80%

0

ANGIO-CONRAY

IOTHALAMATE SODIUM

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1996-04-26	STANDARD
LABELING; Labeling	SUPPL	19	AP	1996-04-26
LABELING; Labeling	SUPPL	21	AP	1976-05-06
LABELING; Labeling	SUPPL	22	AP	1996-04-26
LABELING; Labeling	SUPPL	24	AP	1996-04-26
LABELING; Labeling	SUPPL	25	AP	1996-04-26
LABELING; Labeling	SUPPL	27	AP	1982-10-19
LABELING; Labeling	SUPPL	30	AP	1985-04-16
LABELING; Labeling	SUPPL	33	AP	1989-06-28

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 13319
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANGIO-CONRAY","activeIngredients":"IOTHALAMATE SODIUM","strength":"80%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ANGIO-CONRAY","submission":"IOTHALAMATE SODIUM","actionType":"80%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)