NDA 050625

NOVARTIS

FDA Drug Application

Application #050625

Documents

• Letter: 2004-06-17
• Letter: 2004-06-17
• Letter: 2005-07-26
• 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: 2004-06-17
• Letter: 2006-03-23
• Letter: 2009-11-10
• Letter: 2010-05-06
• Letter: 2013-05-07
• Letter: 2015-04-02
• Label: 2003-03-05
• Label: 2004-03-03
• Label: 2013-05-09
• Letter: 2022-04-14
• Label: 2022-04-20

Application Sponsors

NDA 050625

NOVARTIS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	CAPSULE;ORAL	25MG	1	SANDIMMUNE	CYCLOSPORINE
002	CAPSULE;ORAL	100MG	1	SANDIMMUNE	CYCLOSPORINE
003	CAPSULE;ORAL	50MG	1	SANDIMMUNE	CYCLOSPORINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1990-03-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1991-11-21	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1990-08-24
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1992-12-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1992-12-30	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1991-06-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-02-21	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1992-11-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1993-03-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1992-11-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1993-05-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1994-05-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1994-05-09	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1995-03-07	PRIORITY
LABELING; Labeling	SUPPL	19	AP	1994-11-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1995-01-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1995-11-21	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1995-11-21	STANDARD
LABELING; Labeling	SUPPL	23	AP	1996-08-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1996-04-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1998-03-30	PRIORITY
LABELING; Labeling	SUPPL	27	AP	2000-10-04	STANDARD
LABELING; Labeling	SUPPL	28	AP	1999-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2000-06-30	PRIORITY
LABELING; Labeling	SUPPL	30	AP	2003-02-14	STANDARD
LABELING; Labeling	SUPPL	32	AP	2003-02-14	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2002-01-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	2002-04-12	PRIORITY
LABELING; Labeling	SUPPL	39	AP	2004-02-06	STANDARD
LABELING; Labeling	SUPPL	40	AP	2004-02-06	STANDARD
LABELING; Labeling	SUPPL	43	AP	2005-07-19	STANDARD
LABELING; Labeling	SUPPL	44	AP	2006-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	45	AP	2007-07-20	N/A
LABELING; Labeling	SUPPL	47	AP	2009-10-08	UNKNOWN
LABELING; Labeling	SUPPL	48	AP	2010-04-30	UNKNOWN
LABELING; Labeling	SUPPL	49	AP	2012-08-30	STANDARD
LABELING; Labeling	SUPPL	53	AP	2013-05-03	STANDARD
LABELING; Labeling	SUPPL	55	AP	2015-03-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	57	AP	2016-01-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	2022-03-16	N/A

Submissions Property Types

SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	29	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	47	Null	7
SUPPL	48	Null	7
SUPPL	49	Null	15
SUPPL	53	Null	6
SUPPL	55	Null	31
SUPPL	57	Null	0

TE Codes

001	Prescription	AB2
002	Prescription	AB2
003	Prescription	BX

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50625
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)