NDA 017264

GE HEALTHCARE

FDA Drug Application

Application #017264

Application Sponsors

NDA 017264

GE HEALTHCARE

Marketing Status

• Discontinued: 002

Application Products

002

INJECTABLE;INJECTION

N/A

0

TECHNETIUM TC-99M PENTETATE KIT

TECHNETIUM TC-99M PENTETATE KIT

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1974-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1975-09-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1976-04-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1976-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1977-04-26	STANDARD
LABELING; Labeling	SUPPL	9	AP	1979-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1979-09-13	STANDARD
LABELING; Labeling	SUPPL	12	AP	1979-09-13	STANDARD
LABELING; Labeling	SUPPL	13	AP	1979-09-13	STANDARD
LABELING; Labeling	SUPPL	14	AP	1979-09-13	STANDARD
LABELING; Labeling	SUPPL	18	AP	1980-08-15	STANDARD
LABELING; Labeling	SUPPL	20	AP	1982-10-08	STANDARD
LABELING; Labeling	SUPPL	21	AP	1982-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1989-02-17	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0

CDER Filings

GE HEALTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17264
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TECHNETIUM TC-99M PENTETATE KIT","activeIngredients":"TECHNETIUM TC-99M PENTETATE KIT","strength":"N\/A","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TECHNETIUM TC-99M PENTETATE KIT","submission":"TECHNETIUM TC-99M PENTETATE KIT","actionType":"N\/A","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)