NDA 050440

LILLY

FDA Drug Application

Application #050440

Application Sponsors

NDA 050440

LILLY

Marketing Status

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

Application Products

001	TABLET;ORAL	EQ 500MG BASE	0	KEFLET	CEPHALEXIN
002	TABLET;ORAL	EQ 1GM BASE	0	KEFLET	CEPHALEXIN
003	TABLET;ORAL	EQ 250MG BASE	0	KEFLET	CEPHALEXIN

FDA Submissions

	ORIG	1	AP	1972-10-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1983-02-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1983-08-15
LABELING; Labeling	SUPPL	4	AP	1983-09-28
LABELING; Labeling	SUPPL	5	AP	1983-09-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1984-09-05
LABELING; Labeling	SUPPL	7	AP	1985-09-06
LABELING; Labeling	SUPPL	8	AP	1985-11-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1987-01-27
LABELING; Labeling	SUPPL	11	AP	1986-07-16
LABELING; Labeling	SUPPL	18	AP	1990-04-10
LABELING; Labeling	SUPPL	19	AP	1991-07-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1974-12-27
LABELING; Labeling	SUPPL	21	AP	1975-06-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1975-10-20
LABELING; Labeling	SUPPL	23	AP	1975-11-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1976-11-08
LABELING; Labeling	SUPPL	25	AP	1976-11-02
LABELING; Labeling	SUPPL	26	AP	1977-02-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1977-03-11
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1977-05-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1978-05-18
EFFICACY; Efficacy	SUPPL	30	AP	1978-11-07
LABELING; Labeling	SUPPL	31	AP	1979-01-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1979-04-20
LABELING; Labeling	SUPPL	34	AP	1979-05-21
LABELING; Labeling	SUPPL	35	AP	1979-11-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	36	AP	1980-03-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1980-03-19
LABELING; Labeling	SUPPL	38	AP	1980-05-12
LABELING; Labeling	SUPPL	39	AP	1980-12-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1981-02-11
LABELING; Labeling	SUPPL	41	AP	1981-09-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1982-03-09
EFFICACY; Efficacy	SUPPL	43	AP	1982-09-17
LABELING; Labeling	SUPPL	44	AP	1982-09-17
LABELING; Labeling	SUPPL	45	AP	1982-09-17

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
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	11	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	25	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50440
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)