BLA 103764

NOVARTIS

FDA Drug Application

Application #103764

Documents

• Letter: 2004-03-29
• Letter: 2004-03-29
• Label: 2004-03-29
• Letter: 2004-03-29
• Letter: 2003-12-04
• Label: 2004-03-29
• Label: 2004-03-29
• Review: 2004-03-29

Application Sponsors

BLA 103764

NOVARTIS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	VIAL; SINGLE-USE	10MG	0	SIMULECT	BASILIXIMAB
002	VIAL; SINGLE-USE	20MG	0	SIMULECT	BASILIXIMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1998-05-12	PRIORITY
EFFICACY; Efficacy	SUPPL	1010	AP	2001-03-22	STANDARD
EFFICACY; Efficacy	SUPPL	5003	AP	2001-03-23	STANDARD
LABELING; Labeling	SUPPL	5006	AP	2001-11-29	STANDARD
S; Supplement	SUPPL	5037	AP	2003-01-02
LABELING; Labeling	SUPPL	5040	AP	2003-11-14	STANDARD
LABELING; Labeling	SUPPL	5046	AP	2003-05-27	STANDARD
LABELING; Labeling	SUPPL	5059	AP	2005-09-15	STANDARD

Submissions Property Types

ORIG	1	Orphan	5
SUPPL	1010	Orphan	5
SUPPL	5003	Null	15
SUPPL	5037	Null	0
SUPPL	5040	Orphan	5
SUPPL	5046	Null	15

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 103764
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)