NDA 050716

NOVARTIS

FDA Drug Application

Application #050716

Documents

• Letter: 2002-06-12
• Letter: 2004-02-27
• Letter: 2005-07-26
• 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: 2004-03-03
• Label: 2005-07-26
• Label: 2006-03-10
• Label: 2007-08-02
• Label: 2009-10-01
• Label: 2012-08-31
• Label: 2013-05-09
• Label: 2019-03-07
• Letter: 2002-06-12
• Letter: 2004-02-27
• Letter: 2006-03-23
• Letter: 2013-05-07
• Label: 2002-06-12
• Label: 2004-03-03
• Label: 2009-10-14

Application Sponsors

NDA 050716

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

100MG/ML

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
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1998-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1998-07-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1998-07-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-05-13	STANDARD
LABELING; Labeling	SUPPL	11	AP	2000-10-04	STANDARD
LABELING; Labeling	SUPPL	12	AP	1999-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	2000-11-29	STANDARD
LABELING; Labeling	SUPPL	14	AP	2002-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	2001-05-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2002-02-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	2002-04-12	STANDARD
LABELING; Labeling	SUPPL	18	AP	2002-06-12	STANDARD
LABELING; Labeling	SUPPL	20	AP	2004-02-06	STANDARD
LABELING; Labeling	SUPPL	21	AP	2004-02-06	STANDARD
LABELING; Labeling	SUPPL	24	AP	2005-07-19	STANDARD
LABELING; Labeling	SUPPL	25	AP	2006-03-06	STANDARD
LABELING; Labeling	SUPPL	26	AP	2007-08-01	STANDARD
LABELING; Labeling	SUPPL	28	AP	2009-09-24	STANDARD
LABELING; Labeling	SUPPL	29	AP	2009-10-08	901 REQUIRED
LABELING; Labeling	SUPPL	30	AP	2012-08-30	STANDARD
LABELING; Labeling	SUPPL	34	AP	2013-05-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2013-08-29	STANDARD
LABELING; Labeling	SUPPL	38	AP	2015-03-31	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	13	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	28	Null	7
SUPPL	29	Null	6
SUPPL	30	Null	6
SUPPL	34	Null	7
SUPPL	35	Null	0
SUPPL	38	Null	6

TE Codes

001

Prescription

AB1

CDER Filings

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            [ApplNo] => 50716
            [companyName] => 
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            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)