NDA 016666

MALLINCKRODT

FDA Drug Application

Application #016666

Application Sponsors

NDA 016666

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

0.25mCi/ML

0

HIPPURAN I 131

IODOHIPPURATE SODIUM I-131

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1968-05-24	STANDARD
LABELING; Labeling	SUPPL	6	AP	1975-12-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1977-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1977-08-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1978-04-07	STANDARD
LABELING; Labeling	SUPPL	12	AP	1982-08-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1982-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-05-15	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16666
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"HIPPURAN I 131","activeIngredients":"IODOHIPPURATE SODIUM I-131","strength":"0.25mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HIPPURAN I 131","submission":"IODOHIPPURATE SODIUM I-131","actionType":"0.25mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)