NDA 017820

LILLY

FDA Drug Application

Application #017820

Documents

• Letter: 2002-07-23
• Review: 1998-07-29
• Review: 2002-07-23

Application Sponsors

NDA 017820

LILLY

Marketing Status

• Discontinued: 002

Application Products

002

INJECTABLE;INJECTION

EQ 12.5MG BASE/ML

1

DOBUTREX

DOBUTAMINE HYDROCHLORIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1978-07-18	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1978-09-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1980-08-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1981-02-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1981-06-17	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1986-09-08	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1982-02-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-06-24	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-07-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1986-03-07	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1986-03-07	PRIORITY
LABELING; Labeling	SUPPL	15	AP	1987-01-21	PRIORITY
LABELING; Labeling	SUPPL	16	AP	1987-05-27	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1987-01-21	PRIORITY
LABELING; Labeling	SUPPL	18	AP	1987-05-27	PRIORITY
LABELING; Labeling	SUPPL	19	AP	1988-04-21	PRIORITY
LABELING; Labeling	SUPPL	20	AP	1989-06-23	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1989-04-18	PRIORITY
LABELING; Labeling	SUPPL	22	AP	1989-12-07	PRIORITY
LABELING; Labeling	SUPPL	23	AP	1991-04-26	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1990-12-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1993-02-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1993-02-09	PRIORITY
LABELING; Labeling	SUPPL	27	AP	1994-04-20	PRIORITY
LABELING; Labeling	SUPPL	29	AP	1995-03-30	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	1995-03-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1996-01-11	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1995-11-09	PRIORITY
LABELING; Labeling	SUPPL	33	AP	1996-03-06	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1997-01-08	PRIORITY
LABELING; Labeling	SUPPL	36	AP	1998-07-29	PRIORITY
LABELING; Labeling	SUPPL	37	AP	2002-07-23	PRIORITY

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	10	Null	0
SUPPL	11	Null	0
SUPPL	13	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
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	29	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	33	Null	0
SUPPL	34	Null	0
SUPPL	36	Null	0
SUPPL	37	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17820
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)