NDA 050521

LILLY

FDA Drug Application

Application #050521

Documents

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

Application Sponsors

NDA 050521

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	CECLOR	CEFACLOR
002	CAPSULE;ORAL	EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	CECLOR	CEFACLOR

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1979-04-04	STANDARD
LABELING; Labeling	SUPPL	10	AP	1996-05-01	STANDARD
LABELING; Labeling	SUPPL	11	AP	1996-05-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1991-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1994-03-10	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1991-11-08	STANDARD
LABELING; Labeling	SUPPL	15	AP	1993-05-28	STANDARD
LABELING; Labeling	SUPPL	16	AP	1995-04-13	STANDARD
LABELING; Labeling	SUPPL	17	AP	1996-03-06	STANDARD
LABELING; Labeling	SUPPL	18	AP	1996-09-30	STANDARD
LABELING; Labeling	SUPPL	21	AP	1998-02-02	STANDARD
LABELING; Labeling	SUPPL	22	AP	1998-09-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1999-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2000-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2000-04-27	STANDARD
LABELING; Labeling	SUPPL	26	AP	2003-03-03	STANDARD
LABELING; Labeling	SUPPL	27	AP	2004-03-17	STANDARD

Submissions Property Types

ORIG	1	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	16	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50521
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)