NDA 018310

COVIDIEN

FDA Drug Application

Application #018310

Documents

• Label: 2007-11-07
• Letter: 2007-11-08

Application Sponsors

NDA 018310

COVIDIEN

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

LYMPHAZURIN

ISOSULFAN BLUE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1981-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-05-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1987-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1987-10-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1990-07-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1995-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2001-07-26	STANDARD
LABELING; Labeling	SUPPL	11	AP	2007-10-29	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
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	11	Null	0

CDER Filings

COVIDIEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18310
            [companyName] => COVIDIEN
            [docInserts] => ["",""]
            [products] => [{"drugName":"LYMPHAZURIN","activeIngredients":"ISOSULFAN BLUE","strength":"1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/29\/2007","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/018310s011lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"LYMPHAZURIN","submission":"ISOSULFAN BLUE","actionType":"1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2007-10-29
        )

)