NDA 050573

NOVARTIS

FDA Drug Application

Application #050573

Documents

• Letter: 2004-06-17
• Letter: 2004-06-17
• Letter: 2004-02-27
• Letter: 2005-07-26
• Letter: 2006-03-23
• Letter: 2009-11-10
• Letter: 2010-05-06
• Letter: 2012-09-05
• Label: 2003-03-05
• Label: 2004-03-03
• Label: 2005-07-26
• Label: 2006-03-10
• Label: 2009-10-14
• Label: 2010-05-07
• Label: 2012-08-31
• Label: 2015-04-01
• Letter: 2004-02-27
• Letter: 2013-05-07
• Letter: 2015-04-02
• Label: 2003-03-05
• Label: 2004-03-03
• Label: 2013-05-09

Application Sponsors

NDA 050573

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

50MG/ML

1

SANDIMMUNE

CYCLOSPORINE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1983-11-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-03-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1993-03-19	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1991-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-02-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1993-03-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1994-05-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1994-05-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1995-03-07	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1994-11-10	STANDARD
LABELING; Labeling	SUPPL	12	AP	1996-08-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1996-08-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1998-03-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-10-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1999-05-13	PRIORITY
LABELING; Labeling	SUPPL	17	AP	1999-12-21	STANDARD
LABELING; Labeling	SUPPL	18	AP	2000-10-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2001-04-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2001-03-09	PRIORITY
LABELING; Labeling	SUPPL	21	AP	2003-02-14	STANDARD
LABELING; Labeling	SUPPL	23	AP	2003-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2002-01-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2002-04-12	PRIORITY
LABELING; Labeling	SUPPL	27	AP	2004-02-06	STANDARD
LABELING; Labeling	SUPPL	28	AP	2004-02-06	STANDARD
LABELING; Labeling	SUPPL	30	AP	2005-07-19	STANDARD
LABELING; Labeling	SUPPL	31	AP	2006-03-06	STANDARD
LABELING; Labeling	SUPPL	33	AP	2009-10-08	UNKNOWN
LABELING; Labeling	SUPPL	34	AP	2010-04-30	UNKNOWN
LABELING; Labeling	SUPPL	35	AP	2012-08-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2013-02-07	PRIORITY
LABELING; Labeling	SUPPL	39	AP	2013-05-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	2015-11-02	PRIORITY
LABELING; Labeling	SUPPL	41	AP	2015-03-31	STANDARD

Submissions Property Types

SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	33	Null	7
SUPPL	34	Null	6
SUPPL	35	Null	6
SUPPL	38	Null	0
SUPPL	39	Null	6
SUPPL	40	Null	0
SUPPL	41	Null	15

TE Codes

001

Prescription

AP

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50573
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)