NDA 021994

NOVARTIS

FDA Drug Application

Application #021994

Documents

• Letter: 2006-09-25
• Label: 2006-09-25
• Label: 2011-09-12
• Letter: 2010-09-02
• Letter: 2011-09-12
• Label: 2010-09-07
• Review: 2008-05-07
• Letter: 2017-09-26
• Label: 2017-09-26
• Letter: 2020-04-03
• Label: 2020-04-10

Application Sponsors

NDA 021994

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION/DROPS;OPHTHALMIC

0.004%

1

TRAVATAN Z

TRAVOPROST

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2006-09-21	STANDARD
LABELING; Labeling	SUPPL	6	AP	2011-09-07	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2016-03-11	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-09-22	STANDARD
LABELING; Labeling	SUPPL	13	AP	2020-04-02	STANDARD

Submissions Property Types

SUPPL	1	Null	6
SUPPL	6	Null	7
SUPPL	9	Null	0
SUPPL	12	Null	7
SUPPL	13	Null	7

TE Codes

001

Prescription

AT

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21994
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)