NDA 016729

MALLINCKRODT

FDA Drug Application

Application #016729

Application Sponsors

NDA 016729

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

25uCi/ML

0

FERROUS CITRATE FE 59

FERROUS CITRATE, FE-59

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1973-12-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1977-07-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1977-08-23	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-05-10	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1984-05-24

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16729
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"FERROUS CITRATE FE 59","activeIngredients":"FERROUS CITRATE, FE-59","strength":"25uCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FERROUS CITRATE FE 59","submission":"FERROUS CITRATE, FE-59","actionType":"25uCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)