NDA 011777

MALLINCKRODT

FDA Drug Application

Application #011777

Application Sponsors

NDA 011777

MALLINCKRODT

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	SOLUTION;INJECTION, ORAL	0.67mCi/ML	0	SODIUM PHOSPHATE P 32	SODIUM PHOSPHATE P-32
002	SOLUTION;INJECTION, ORAL	1.5mCi/VIAL	0	SODIUM PHOSPHATE P 32	SODIUM PHOSPHATE P-32

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1959-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1977-01-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1977-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1977-11-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1977-08-23	STANDARD
LABELING; Labeling	SUPPL	13	AP	1980-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1982-05-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1990-05-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1993-10-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1994-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1998-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-08-28	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	21	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11777
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"SODIUM PHOSPHATE P 32","activeIngredients":"SODIUM PHOSPHATE P-32","strength":"0.67mCi\/ML","dosageForm":"SOLUTION;INJECTION, ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SODIUM PHOSPHATE P 32","activeIngredients":"SODIUM PHOSPHATE P-32","strength":"1.5mCi\/VIAL","dosageForm":"SOLUTION;INJECTION, ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SODIUM PHOSPHATE P 32","submission":"SODIUM PHOSPHATE P-32","actionType":"0.67mCi\/ML","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SODIUM PHOSPHATE P 32","submission":"SODIUM PHOSPHATE P-32","actionType":"1.5mCi\/VIAL","submissionClassification":"SOLUTION;INJECTION, ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)