NDA 050673

LILLY

FDA Drug Application

Application #050673

Application Sponsors

NDA 050673

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 375MG BASE	0	CECLOR CD	CEFACLOR
002	TABLET, EXTENDED RELEASE;ORAL	EQ 500MG BASE	0	CECLOR CD	CEFACLOR

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1996-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1998-02-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1999-11-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2000-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-12-08	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50673
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)