NDA 014103

LILLY

FDA Drug Application

Application #014103

Application Sponsors

NDA 014103

LILLY

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	1MG/VIAL	0	ONCOVIN	VINCRISTINE SULFATE
002	INJECTABLE;INJECTION	5MG/VIAL	0	ONCOVIN	VINCRISTINE SULFATE
003	INJECTABLE;INJECTION	1MG/ML	0	ONCOVIN	VINCRISTINE SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1963-07-10	PRIORITY
LABELING; Labeling	SUPPL	16	AP	1976-03-12
LABELING; Labeling	SUPPL	19	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1982-04-08	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1981-05-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1981-07-02	PRIORITY
EFFICACY; Efficacy	SUPPL	24	AP	1982-12-09
LABELING; Labeling	SUPPL	25	AP	2007-12-07
LABELING; Labeling	SUPPL	26	AP	1982-05-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	1985-05-31	PRIORITY
LABELING; Labeling	SUPPL	28	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1983-09-20	PRIORITY
LABELING; Labeling	SUPPL	30	AP	1984-03-07
LABELING; Labeling	SUPPL	31	AP	1985-09-23
EFFICACY; Efficacy	SUPPL	32	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1985-08-16	PRIORITY
LABELING; Labeling	SUPPL	34	AP	2007-12-07
LABELING; Labeling	SUPPL	35	AP	1986-03-17
LABELING; Labeling	SUPPL	36	AP	1986-01-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1987-02-19	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1987-07-23	PRIORITY
LABELING; Labeling	SUPPL	39	AP	1987-08-17
LABELING; Labeling	SUPPL	40	AP	1988-04-05
LABELING; Labeling	SUPPL	41	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1988-06-22	PRIORITY
LABELING; Labeling	SUPPL	43	AP	1988-09-16
LABELING; Labeling	SUPPL	44	AP	1989-06-06
LABELING; Labeling	SUPPL	45	AP	2007-12-07
LABELING; Labeling	SUPPL	46	AP	1990-06-14
MANUF (CMC); Manufacturing (CMC)	SUPPL	47	AP	1991-04-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	48	AP	1991-01-02	PRIORITY
LABELING; Labeling	SUPPL	49	AP	1992-04-02
LABELING; Labeling	SUPPL	50	AP	1992-06-30
LABELING; Labeling	SUPPL	51	AP	1992-12-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	52	AP	1995-07-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	1996-03-28	PRIORITY
LABELING; Labeling	SUPPL	54	AP	2007-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	55	AP	1995-11-06	PRIORITY
LABELING; Labeling	SUPPL	56	AP	2007-12-07	STANDARD
LABELING; Labeling	SUPPL	57	AP	2007-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	58	AP	1997-10-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	59	AP	1998-04-29	PRIORITY
LABELING; Labeling	SUPPL	60	AP	1999-08-26	STANDARD
LABELING; Labeling	SUPPL	61	AP	2007-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	62	AP	2001-01-02	PRIORITY
LABELING; Labeling	SUPPL	63	AP	2007-12-07	STANDARD

Submissions Property Types

SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	33	Null	0
SUPPL	37	Null	0
SUPPL	38	Null	0
SUPPL	42	Null	0
SUPPL	47	Null	0
SUPPL	48	Null	0
SUPPL	52	Null	0
SUPPL	53	Null	0
SUPPL	55	Null	0
SUPPL	58	Null	0
SUPPL	59	Null	0
SUPPL	62	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 14103
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)