NDA 021862

NOVARTIS

FDA Drug Application

Application #021862

Documents

• Letter: 2005-08-23
• Letter: 2011-07-05
• Label: 2005-08-23
• Label: 2011-06-27
• Label: 2008-06-12
• Review: 2005-10-06
• Letter: 2017-12-20
• Label: 2017-12-22
• Letter: 2020-11-05
• Label: 2020-11-09

Application Sponsors

NDA 021862

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SUSPENSION/DROPS;OPHTHALMIC

0.1%

1

NEVANAC

NEPAFENAC

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2005-08-19	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2008-05-08	STANDARD
LABELING; Labeling	SUPPL	8	AP	2011-06-27	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2014-03-07	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2017-12-15	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-11-04	STANDARD

Submissions Property Types

SUPPL	8	Null	6
SUPPL	10	Null	0
SUPPL	13	Null	7
SUPPL	17	Null	15

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21862
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)