NDA 012665

LILLY

FDA Drug Application

Application #012665

Application Sponsors

NDA 012665

LILLY

Marketing Status

• Discontinued: 001

Application Products

001

INJECTABLE;INJECTION

10MG/VIAL

1

VELBAN

VINBLASTINE SULFATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1965-11-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1980-06-20	PRIORITY
LABELING; Labeling	SUPPL	8	AP	1978-09-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1979-01-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1981-07-02	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1986-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-01-15	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2007-12-07
LABELING; Labeling	SUPPL	14	AP	1986-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1987-01-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1987-10-16	PRIORITY
LABELING; Labeling	SUPPL	17	AP	2007-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1987-05-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1987-03-19	PRIORITY
LABELING; Labeling	SUPPL	20	AP	1987-08-25
LABELING; Labeling	SUPPL	21	AP	1988-04-18
LABELING; Labeling	SUPPL	22	AP	1989-06-06
LABELING; Labeling	SUPPL	23	AP	1989-06-06
LABELING; Labeling	SUPPL	24	AP	1990-08-10
LABELING; Labeling	SUPPL	25	AP	1990-06-18
LABELING; Labeling	SUPPL	26	AP	2007-12-07
LABELING; Labeling	SUPPL	27	AP	1992-07-31
LABELING; Labeling	SUPPL	28	AP	1992-12-16	STANDARD
LABELING; Labeling	SUPPL	29	AP	1993-09-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1995-07-05	PRIORITY
LABELING; Labeling	SUPPL	31	AP	1996-12-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1995-11-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	1996-10-21	PRIORITY
LABELING; Labeling	SUPPL	34	AP	2007-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1997-09-02	PRIORITY
LABELING; Labeling	SUPPL	36	AP	2007-12-07	STANDARD
LABELING; Labeling	SUPPL	37	AP	2007-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	1999-03-04	PRIORITY
LABELING; Labeling	SUPPL	39	AP	2000-08-24	STANDARD
LABELING; Labeling	SUPPL	40	AP	2007-12-07	STANDARD

Submissions Property Types

SUPPL	7	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	30	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	35	Null	0
SUPPL	38	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12665
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)