NDA 019937

ASTELLAS

FDA Drug Application

Application #019937

Documents

• Label: 2009-11-19
• Letter: 2005-07-21
• Letter: 2010-01-07

Application Sponsors

NDA 019937

ASTELLAS

Marketing Status

• Discontinued: 002

Application Products

002

INJECTABLE;INJECTION

3MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

ADENOCARD

ADENOSINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1989-10-30	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1990-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1994-04-25	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1990-09-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1990-11-15	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1992-06-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1993-10-27	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1995-06-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-06-26	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1996-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-12-27	PRIORITY
LABELING; Labeling	SUPPL	13	AP	1996-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1997-02-13	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1999-04-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-11-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2000-02-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2001-09-21	PRIORITY
LABELING; Labeling	SUPPL	21	AP	2005-07-14	STANDARD
LABELING; Labeling	SUPPL	24	AP	2009-11-06	STANDARD
LABELING; Labeling	SUPPL	26	AP	2011-02-23	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2013-12-13	PRIORITY

Submissions Property Types

SUPPL	1	Null	0
SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	24	Null	7
SUPPL	26	Null	7
SUPPL	28	Null	0

CDER Filings

ASTELLAS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 19937
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ADENOCARD","activeIngredients":"ADENOSINE","strength":"3MG\/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]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":"11\/06\/2009","submission":"SUPPL-24","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/019937s024lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ADENOCARD","submission":"ADENOSINE","actionType":"3MG\/ML **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] => 2009-11-06
        )

)