NDA 050514

NOVARTIS

FDA Drug Application

Application #050514

Documents

• Letter: 2008-07-23
• Label: 2008-07-22
• Review: 2021-09-24

Application Sponsors

NDA 050514

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION;OPHTHALMIC

5%

1

NATACYN

NATAMYCIN

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1978-10-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1991-03-08	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1992-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1992-02-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-11-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1997-05-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	2000-10-19	PRIORITY
LABELING; Labeling	SUPPL	9	AP	2008-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-12-04	PRIORITY

Submissions Property Types

SUPPL	3	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50514
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)