NDA 050504

LILLY

FDA Drug Application

Application #050504

Documents

• Letter: 2002-07-18
• Letter: 2003-03-10

Application Sponsors

NDA 050504

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	INJECTABLE;INJECTION	EQ 500MG BASE/VIAL	0	MANDOL	CEFAMANDOLE NAFATE
002	INJECTABLE;INJECTION	EQ 1GM BASE/VIAL	0	MANDOL	CEFAMANDOLE NAFATE
003	INJECTABLE;INJECTION	EQ 2GM BASE/VIAL	0	MANDOL	CEFAMANDOLE NAFATE
004	INJECTABLE;INJECTION	EQ 10GM BASE/VIAL	0	MANDOL	CEFAMANDOLE NAFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1978-09-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1982-11-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1982-12-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1983-02-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1983-02-17	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1983-03-18
LABELING; Labeling	SUPPL	7	AP	1983-03-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1981-11-19	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1983-06-20
LABELING; Labeling	SUPPL	10	AP	1983-06-21
LABELING; Labeling	SUPPL	11	AP	2009-03-13
LABELING; Labeling	SUPPL	12	AP	1983-08-05
LABELING; Labeling	SUPPL	13	AP	1983-08-24
LABELING; Labeling	SUPPL	14	AP	1983-09-06
LABELING; Labeling	SUPPL	15	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1984-02-28	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1984-09-07	PRIORITY
LABELING; Labeling	SUPPL	18	AP	2009-03-13
LABELING; Labeling	SUPPL	19	AP	1982-07-15
LABELING; Labeling	SUPPL	20	AP	2009-03-13
LABELING; Labeling	SUPPL	21	AP	1986-03-12
LABELING; Labeling	SUPPL	22	AP	1986-03-12
LABELING; Labeling	SUPPL	23	AP	1982-07-29
LABELING; Labeling	SUPPL	24	AP	2009-03-13
LABELING; Labeling	SUPPL	25	AP	1995-05-10
LABELING; Labeling	SUPPL	26	AP	1982-09-03
LABELING; Labeling	SUPPL	27	AP	1991-06-13
LABELING; Labeling	SUPPL	28	AP	1993-06-18
LABELING; Labeling	SUPPL	29	AP	1992-10-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1978-11-15	PRIORITY
LABELING; Labeling	SUPPL	31	AP	1978-11-21
LABELING; Labeling	SUPPL	32	AP	1979-01-15
LABELING; Labeling	SUPPL	33	AP	1979-02-06
LABELING; Labeling	SUPPL	34	AP	1979-03-21
EFFICACY; Efficacy	SUPPL	35	AP	1979-08-01
LABELING; Labeling	SUPPL	36	AP	1979-05-15
LABELING; Labeling	SUPPL	37	AP	1979-08-01
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1979-09-10	PRIORITY
LABELING; Labeling	SUPPL	39	AP	1979-11-13
LABELING; Labeling	SUPPL	40	AP	1980-04-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1980-05-01	PRIORITY
LABELING; Labeling	SUPPL	42	AP	1980-05-01
LABELING; Labeling	SUPPL	43	AP	1980-05-28
LABELING; Labeling	SUPPL	44	AP	1980-06-17
LABELING; Labeling	SUPPL	45	AP	1980-07-01
LABELING; Labeling	SUPPL	46	AP	1980-10-03
LABELING; Labeling	SUPPL	47	AP	1980-10-28
LABELING; Labeling	SUPPL	48	AP	1980-11-20
LABELING; Labeling	SUPPL	49	AP	1980-11-20
LABELING; Labeling	SUPPL	50	AP	1980-11-20
LABELING; Labeling	SUPPL	51	AP	1980-11-20
LABELING; Labeling	SUPPL	52	AP	1980-11-23
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1981-02-11	PRIORITY
LABELING; Labeling	SUPPL	54	AP	1981-09-04
LABELING; Labeling	SUPPL	55	AP	1981-11-16
LABELING; Labeling	SUPPL	57	AP	1992-12-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1993-03-23	PRIORITY
LABELING; Labeling	SUPPL	59	AP	2002-07-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	60	AP	1996-06-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	61	AP	1999-01-05	PRIORITY
LABELING; Labeling	SUPPL	62	AP	2003-03-04	STANDARD
LABELING; Labeling	SUPPL	63	AP	2009-03-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	64	AP	2002-05-22	PRIORITY

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	8	Null	0
SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	30	Null	0
SUPPL	38	Null	0
SUPPL	41	Null	0
SUPPL	53	Null	0
SUPPL	58	Null	0
SUPPL	60	Null	0
SUPPL	61	Null	0
SUPPL	64	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 50504
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)