NDA 020920

SCIOS LLC

FDA Drug Application

Application #020920

Documents

• Letter: 2001-08-10
• Letter: 2005-04-28
• Letter: 2006-12-28
• Letter: 2009-06-17
• Letter: 2012-07-09
• Letter: 2013-04-30
• Label: 2007-04-16
• Label: 2009-06-22
• Label: 2012-07-10
• Label: 2013-04-30
• Letter: 2004-07-06
• Letter: 2005-05-02
• Label: 2001-08-10
• Label: 2005-04-28
• Review: 2001-08-10
• Label: 2019-01-10
• Letter: 2019-01-23

Application Sponsors

NDA 020920

SCIOS LLC

Marketing Status

• Discontinued: 001

Application Products

001

FOR SOLUTION;INTRAVENOUS

1.5MG/VIAL

1

NATRECOR

NESIRITIDE RECOMBINANT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2001-08-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2004-07-02	STANDARD
LABELING; Labeling	SUPPL	6	AP	2005-04-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2005-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2006-12-27	N/A
LABELING; Labeling	SUPPL	12	AP	2006-11-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2007-03-28	N/A
LABELING; Labeling	SUPPL	23	AP	2009-06-12	STANDARD
LABELING; Labeling	SUPPL	31	AP	2012-07-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2012-11-09	STANDARD
LABELING; Labeling	SUPPL	33	AP	2013-04-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2014-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2015-07-31	STANDARD
LABELING; Labeling	SUPPL	36	AP	2019-01-09	STANDARD

Submissions Property Types

SUPPL	31	Null	7
SUPPL	32	Null	0
SUPPL	33	Null	15
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	6

CDER Filings

SCIOS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20920
            [companyName] => SCIOS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NATRECOR","activeIngredients":"NESIRITIDE RECOMBINANT","strength":"1.5MG\/VIAL","dosageForm":"FOR SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"01\/09\/2019","submission":"SUPPL-36","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/020920s036lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2013","submission":"SUPPL-33","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/20920s033lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2012","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020920s031lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2009","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020920s023lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2006","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/020920s012lbl.pdf\"}]","notes":""},{"actionDate":"04\/20\/2005","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020920s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2001","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/20920lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"NATRECOR","submission":"NESIRITIDE RECOMBINANT","actionType":"1.5MG\/VIAL","submissionClassification":"FOR SOLUTION;INTRAVENOUS","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2019-01-09
        )

)