NDA 018110

GE HEALTHCARE

FDA Drug Application

Application #018110

Documents

• Letter: 2005-05-17

Application Sponsors

NDA 018110

GE HEALTHCARE

Marketing Status

• Prescription: 002

Application Products

002

INJECTABLE;INJECTION

1mCi/ML

1

THALLOUS CHLORIDE TL 201

THALLOUS CHLORIDE TL-201

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1982-02-01	STANDARD
LABELING; Labeling	SUPPL	2	AP	1982-10-26
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-01-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1990-06-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-07-13	STANDARD
LABELING; Labeling	SUPPL	6	AP	1996-02-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1995-03-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-01-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-11-14	STANDARD
LABELING; Labeling	SUPPL	12	AP	2005-05-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2016-06-08	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	16	Null	0

TE Codes

002

Prescription

AP

CDER Filings

GE HEALTHCARE

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(
    [0] => Array
        (
            [ApplNo] => 18110
            [companyName] => GE HEALTHCARE
            [docInserts] => ["",""]
            [products] => [{"drugName":"THALLOUS CHLORIDE TL 201","activeIngredients":"THALLOUS CHLORIDE TL-201","strength":"1mCi\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"THALLOUS CHLORIDE TL 201","submission":"THALLOUS CHLORIDE TL-201","actionType":"1mCi\/ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)