NDA 022048

NOVARTIS

FDA Drug Application

Application #022048

Documents

• Letter: 2008-01-09
• Label: 2007-12-03
• Review: 2008-07-08
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01

Application Sponsors

NDA 022048

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INTRAVITREAL

40MG/ML (40MG/ML)

1

TRIESENCE

TRIAMCINOLONE ACETONIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2007-11-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-06-23	PRIORITY

Submissions Property Types

ORIG	1	Null	31
SUPPL	3	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 22048
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)