NDA 020101

LILLY

FDA Drug Application

Application #020101

Documents

• Letter: 2005-02-23
• Letter: 2008-03-24
• Label: 2006-09-21
• Label: 2007-08-03
• Label: 2008-03-24
• Review: 2004-08-09
• Letter: 2004-06-01
• Letter: 2004-08-25
• Letter: 2005-12-05
• Letter: 2006-04-13
• Letter: 2007-03-23
• Letter: 2007-08-07
• Letter: 2008-03-12
• Letter: 2009-02-03
• Label: 2008-03-13
• Label: 2009-02-04
• Other Important Information from FDA: 2005-08-01

Application Sponsors

NDA 020101

LILLY

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

EQ 20MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

1

PROZAC

FLUOXETINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1991-04-24	PRIORITY
LABELING; Labeling	SUPPL	2	AP	1992-01-21	PRIORITY
LABELING; Labeling	SUPPL	3	AP	1992-08-20	PRIORITY
LABELING; Labeling	SUPPL	4	AP	1993-08-18	PRIORITY
LABELING; Labeling	SUPPL	5	AP	1993-03-25	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1995-05-22	PRIORITY
LABELING; Labeling	SUPPL	7	AP	1994-07-06	PRIORITY
LABELING; Labeling	SUPPL	9	AP	1997-03-25	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1995-03-01	PRIORITY
LABELING; Labeling	SUPPL	11	AP	1995-09-12	PRIORITY
LABELING; Labeling	SUPPL	12	AP	1995-09-12	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1996-04-01	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1998-04-23	PRIORITY
LABELING; Labeling	SUPPL	21	AP	1998-03-13	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1998-08-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1998-08-04	PRIORITY
LABELING; Labeling	SUPPL	24	AP	1999-10-07	PRIORITY
LABELING; Labeling	SUPPL	26	AP	1999-06-16	PRIORITY
EFFICACY; Efficacy	SUPPL	27	AP	2002-07-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2004-05-25	PRIORITY
LABELING; Labeling	SUPPL	31	AP	2004-08-19	PRIORITY
LABELING; Labeling	SUPPL	32	AP	2005-12-01	PRIORITY
LABELING; Labeling	SUPPL	33	AP	2005-02-18	PRIORITY
LABELING; Labeling	SUPPL	34	AP	2006-04-11	PRIORITY
LABELING; Labeling	SUPPL	35	AP	2006-09-20	PRIORITY
LABELING; Labeling	SUPPL	36	AP	2007-03-15	PRIORITY
LABELING; Labeling	SUPPL	37	AP	2007-08-02	PRIORITY
LABELING; Labeling	SUPPL	38	AP	2008-03-09	PRIORITY
LABELING; Labeling	SUPPL	39	AP	2008-03-21	PRIORITY
LABELING; Labeling	SUPPL	42	AP	2009-01-30	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	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	26	Null	0
SUPPL	27	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	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	42	Null	0

CDER Filings

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20101
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)