NDA 050715

NOVARTIS

FDA Drug Application

Application #050715

Documents

• Letter: 2002-06-12
• Letter: 2004-06-09
• Letter: 2007-08-02
• Letter: 2009-11-12
• Letter: 2009-11-09
• Letter: 2012-09-05
• Letter: 2015-04-02
• Label: 2002-06-12
• Label: 2004-06-09
• Label: 2005-07-26
• Label: 2006-03-10
• Label: 2007-08-02
• Label: 2009-10-01
• Label: 2012-08-31
• Label: 2013-05-09
• Letter: 2002-06-12
• Letter: 2004-06-09
• Letter: 2005-07-26
• Letter: 2006-03-23
• Letter: 2013-05-07
• Label: 2002-06-12
• Label: 2004-03-03
• Label: 2009-10-14
• Label: 2019-03-07

Application Sponsors

NDA 050715

NOVARTIS

Marketing Status

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

Application Products

001	CAPSULE;ORAL	25MG	1	NEORAL	CYCLOSPORINE
002	CAPSULE;ORAL	100MG	1	NEORAL	CYCLOSPORINE
003	CAPSULE;ORAL	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	NEORAL	CYCLOSPORINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1995-07-14	STANDARD
LABELING; Labeling	SUPPL	4	AP	1997-06-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-03-30	STANDARD
LABELING; Labeling	SUPPL	7	AP	2000-10-04	STANDARD
LABELING; Labeling	SUPPL	8	AP	1999-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2000-06-30	STANDARD
LABELING; Labeling	SUPPL	10	AP	2002-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2002-04-12	STANDARD
LABELING; Labeling	SUPPL	14	AP	2002-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2002-09-26	STANDARD
LABELING; Labeling	SUPPL	19	AP	2004-02-06	STANDARD
LABELING; Labeling	SUPPL	20	AP	2004-02-06	STANDARD
LABELING; Labeling	SUPPL	22	AP	2005-07-19	STANDARD
LABELING; Labeling	SUPPL	24	AP	2006-03-06	STANDARD
LABELING; Labeling	SUPPL	25	AP	2007-08-01	STANDARD
LABELING; Labeling	SUPPL	27	AP	2009-09-24	STANDARD
LABELING; Labeling	SUPPL	28	AP	2009-10-08	901 REQUIRED
LABELING; Labeling	SUPPL	29	AP	2012-08-30	STANDARD
LABELING; Labeling	SUPPL	33	AP	2013-05-02	STANDARD
LABELING; Labeling	SUPPL	35	AP	2015-03-31	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	27	Null	7
SUPPL	28	Null	6
SUPPL	29	Null	6
SUPPL	33	Null	7
SUPPL	35	Null	7

TE Codes

001	Prescription	AB1
002	Prescription	AB1

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 50715
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)