NDA 017454

MALLINCKRODT

FDA Drug Application

Application #017454

Application Sponsors

NDA 017454

MALLINCKRODT

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

N/A

0

OSTEOSCAN

TECHNETIUM TC-99M ETIDRONATE KIT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1973-09-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1975-05-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1976-03-04	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1976-03-04	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1976-03-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1977-01-22	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1977-01-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1977-02-11	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1977-02-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1979-03-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1979-07-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1979-07-17	PRIORITY
LABELING; Labeling	SUPPL	17	AP	1978-02-24	PRIORITY
EFFICACY; Efficacy	SUPPL	18	AP	1978-08-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1979-01-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1980-01-09	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	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	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

MALLINCKRODT

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17454
            [companyName] => MALLINCKRODT
            [docInserts] => ["",""]
            [products] => [{"drugName":"OSTEOSCAN","activeIngredients":"TECHNETIUM TC-99M ETIDRONATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OSTEOSCAN","submission":"TECHNETIUM TC-99M ETIDRONATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)