NDA 050614

LILLY

FDA Drug Application

Application #050614

Application Sponsors

NDA 050614

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	EQ 250MG BASE	0	KEFTAB	CEPHALEXIN HYDROCHLORIDE
002	TABLET;ORAL	EQ 500MG BASE	0	KEFTAB	CEPHALEXIN HYDROCHLORIDE
003	TABLET;ORAL	EQ 333MG BASE	0	KEFTAB	CEPHALEXIN HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1987-10-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1991-03-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1990-11-28	STANDARD
LABELING; Labeling	SUPPL	10	AP	1991-09-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1991-10-25	STANDARD
LABELING; Labeling	SUPPL	13	AP	1993-06-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1988-05-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1993-09-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	1999-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1998-02-19	STANDARD
LABELING; Labeling	SUPPL	18	AP	1999-07-29	STANDARD
LABELING; Labeling	SUPPL	19	AP	1999-07-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	2000-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	2001-06-18	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	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	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50614
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)