NDA 050522

LILLY

FDA Drug Application

Application #050522

Documents

• Letter: 2003-03-10
• Letter: 2004-03-24
• Label: 2004-04-05
• Review: 1998-02-02

Application Sponsors

NDA 050522

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	FOR SUSPENSION;ORAL	EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	CECLOR	CEFACLOR
002	FOR SUSPENSION;ORAL	EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	CECLOR	CEFACLOR

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1979-04-04	STANDARD
LABELING; Labeling	SUPPL	2	AP	1986-08-28	STANDARD
LABELING; Labeling	SUPPL	6	AP	1988-07-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	1996-05-01	STANDARD
LABELING; Labeling	SUPPL	8	AP	1996-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1992-12-08	STANDARD
LABELING; Labeling	SUPPL	11	AP	1995-04-13	STANDARD
LABELING; Labeling	SUPPL	12	AP	1993-05-28	STANDARD
LABELING; Labeling	SUPPL	13	AP	1996-03-06	STANDARD
LABELING; Labeling	SUPPL	14	AP	1996-09-30	STANDARD
LABELING; Labeling	SUPPL	15	AP	1996-03-05	STANDARD
LABELING; Labeling	SUPPL	18	AP	1998-02-02	STANDARD
LABELING; Labeling	SUPPL	19	AP	1998-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-03-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2000-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	2000-04-27	STANDARD
LABELING; Labeling	SUPPL	23	AP	2001-10-12	STANDARD
LABELING; Labeling	SUPPL	24	AP	2003-03-03	STANDARD
LABELING; Labeling	SUPPL	27	AP	2004-03-17	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	27	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50522
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)