NDA 020974

LILLY

FDA Drug Application

Application #020974

Documents

• Letter: 2005-12-05
• Letter: 2005-02-23
• Letter: 2006-04-13
• Review: 1999-03-09
• Letter: 1999-03-09
• Letter: 2004-08-25
• Label: 2006-09-21
• Review: 2014-07-07
• Other Important Information from FDA: 2005-08-01

Application Sponsors

NDA 020974

LILLY

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PROZAC	FLUOXETINE HYDROCHLORIDE
002	TABLET;ORAL	EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PROZAC	FLUOXETINE HYDROCHLORIDE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	1999-03-09	STANDARD
EFFICACY; Efficacy	SUPPL	2	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	3	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	4	AP	2004-08-19	STANDARD
LABELING; Labeling	SUPPL	5	AP	2005-12-01	STANDARD
LABELING; Labeling	SUPPL	6	AP	2005-02-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	2006-04-11	STANDARD
LABELING; Labeling	SUPPL	8	AP	2006-09-20	STANDARD

CDER Filings

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    [0] => Array
        (
            [ApplNo] => 20974
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
            [originalApprovals] => []
            [supplements] => 
            [actionDate] => 0000-00-00
        )

)