NDA 020316

GUERBET

FDA Drug Application

Application #020316

Documents

• Letter: 2002-01-06
• Letter: 2006-11-14
• Letter: 2015-07-23
• Label: 2015-07-23
• Label: 2017-04-06
• Letter: 2017-04-12

Application Sponsors

NDA 020316

GUERBET

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	INJECTABLE;INJECTION	62%	0	OXILAN-300	IOXILAN
002	INJECTABLE;INJECTION	73%	0	OXILAN-350	IOXILAN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1995-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1997-03-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1997-10-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-05-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1999-01-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2002-12-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2001-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-04-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-08-12	STANDARD
LABELING; Labeling	SUPPL	16	AP	2003-01-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2006-11-12	N/A
LABELING; Labeling	SUPPL	28	AP	2015-07-06	STANDARD
LABELING; Labeling	SUPPL	29	AP	2017-04-05	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	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	28	Null	15
SUPPL	29	Null	6

CDER Filings

GUERBET

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20316
            [companyName] => GUERBET
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXILAN-300","activeIngredients":"IOXILAN","strength":"62%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXILAN-350","activeIngredients":"IOXILAN","strength":"73%","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/05\/2017","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020316s029lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2015","submission":"SUPPL-28","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020316Orig1s028lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"OXILAN-300","submission":"IOXILAN","actionType":"62%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXILAN-350","submission":"IOXILAN","actionType":"73%","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2017-04-05
        )

)