LILLY FDA Approval NDA 021520

Application #021520

Documents

Letter	2006-12-28
Letter	2007-04-20
Letter	2007-08-07
Letter	2008-03-19
Letter	2008-03-24
Letter	2008-08-19
Letter	2010-02-01
Letter	2011-04-25
Letter	2010-12-07
Letter	2011-04-25
Letter	2010-12-07
Letter	2011-06-27
Letter	2013-01-07
Letter	2013-01-07
Letter	2013-07-30
Letter	2013-08-08
Letter	2014-10-15
Letter	2014-07-24
Label	2004-01-02
Label	2007-04-20
Label	2009-03-20
Label	2007-08-03
Label	2007-08-03
Label	2008-03-19
Label	2009-09-22
Label	2011-04-26
Label	2010-12-04
Label	2011-06-29
Label	2013-01-07
Label	2012-08-08
Label	2013-08-09
Label	2014-07-23
Review	2013-05-10
Letter	2004-01-02
Letter	2005-02-23
Letter	2007-04-20
Letter	2007-08-07
Letter	2011-06-27
Letter	2011-10-05
Letter	2014-12-23
Letter	2013-07-30
Letter	2012-08-09
Label	2007-04-20
Label	2006-12-04
Label	2008-03-24
Label	2010-01-29
Label	2011-04-26
Label	2010-12-04
Label	2011-06-29
Label	2011-10-05
Label	2015-01-09
Label	2013-01-07
Label	2013-07-30
Label	2013-07-30
Label	2014-10-15
Review	2005-06-16
Patient Package Insert	2004-01-16
Other Important Information from FDA	2007-05-09
Letter	2016-10-14
Label	2016-12-01
Label	2017-01-06
Letter	2017-01-13
Label	2017-02-27
Letter	2017-03-02
Letter	2017-03-02
Label	2017-03-27
Letter	2017-03-29
Label	2017-07-07
Pediatric Medical Review	1900-01-01
Pediatric Clinical Pharmacology Review	1900-01-01
Pediatric Statistical Review	1900-01-01
Pediatric Addendum	1900-01-01
Label	2018-03-28
Medication Guide	2018-03-28
Letter	2018-03-29
Letter	2020-04-22
Label	2020-04-22
Medication Guide	2020-04-22
Letter	2020-10-27
Label	2020-10-27
Medication Guide	2020-10-27
Letter	2021-03-05
Label	2021-03-09
Medication Guide	2021-03-09
Letter	2021-09-23
Label	2021-09-30
Medication Guide	2021-09-30

Application Sponsors

NDA 021520

LILLY

Marketing Status

Prescription	001
Prescription	002
Prescription	003
Prescription	004
Prescription	005

Application Products

001	CAPSULE;ORAL	EQ 25MG BASE;EQ 3MG BASE	1	SYMBYAX	FLUOXETINE HYDROCHLORIDE; OLANZAPINE
002	CAPSULE;ORAL	EQ 25MG BASE;EQ 6MG BASE	1	SYMBYAX	FLUOXETINE HYDROCHLORIDE; OLANZAPINE
003	CAPSULE;ORAL	EQ 50MG BASE;EQ 6MG BASE	1	SYMBYAX	FLUOXETINE HYDROCHLORIDE; OLANZAPINE
004	CAPSULE;ORAL	EQ 25MG BASE;EQ 12MG BASE	1	SYMBYAX	FLUOXETINE HYDROCHLORIDE; OLANZAPINE
005	CAPSULE;ORAL	EQ 50MG BASE;EQ 12MG BASE	1	SYMBYAX	FLUOXETINE HYDROCHLORIDE; OLANZAPINE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2003-12-24	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2006-07-03	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2005-02-18	STANDARD
LABELING; Labeling	SUPPL	6	AP	2006-07-03	PRIORITY
LABELING; Labeling	SUPPL	7	AP	2006-07-03	STANDARD
LABELING; Labeling	SUPPL	8	AP	2007-04-09	STANDARD
LABELING; Labeling	SUPPL	9	AP	2006-11-29	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2007-04-09	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2006-09-20	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2009-03-19	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2007-08-02	STANDARD
LABELING; Labeling	SUPPL	14	AP	2007-08-02	STANDARD
LABELING; Labeling	SUPPL	16	AP	2008-03-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	2008-03-21	STANDARD
LABELING; Labeling	SUPPL	20	AP	2008-08-14	STANDARD
LABELING; Labeling	SUPPL	22	AP	2009-08-31	901 REQUIRED
LABELING; Labeling	SUPPL	23	AP	2010-01-27	UNKNOWN
LABELING; Labeling	SUPPL	25	AP	2011-04-22	UNKNOWN
LABELING; Labeling	SUPPL	27	AP	2010-12-01	UNKNOWN
LABELING; Labeling	SUPPL	28	AP	2011-04-22	UNKNOWN
LABELING; Labeling	SUPPL	29	AP	2010-12-01	901 REQUIRED
REMS; REMS	SUPPL	31	AP	2011-06-21	N/A
REMS; REMS	SUPPL	32	AP	2011-06-21	N/A
LABELING; Labeling	SUPPL	33	AP	2011-10-04	UNKNOWN
LABELING; Labeling	SUPPL	34	AP	2014-12-19	STANDARD
LABELING; Labeling	SUPPL	35	AP	2013-01-03	STANDARD
LABELING; Labeling	SUPPL	36	AP	2013-01-03	STANDARD
LABELING; Labeling	SUPPL	37	AP	2013-07-26	UNKNOWN
LABELING; Labeling	SUPPL	38	AP	2012-08-08	STANDARD
EFFICACY; Efficacy	SUPPL	39	AP	2013-07-26	STANDARD
LABELING; Labeling	SUPPL	40	AP	2013-08-07	STANDARD
EFFICACY; Efficacy	SUPPL	41	AP	2014-10-10	STANDARD
LABELING; Labeling	SUPPL	42	AP	2017-03-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	43	AP	2014-10-30	PRIORITY
LABELING; Labeling	SUPPL	45	AP	2014-07-18	901 REQUIRED
LABELING; Labeling	SUPPL	46	AP	2016-10-06	901 REQUIRED
LABELING; Labeling	SUPPL	47	AP	2017-01-04	901 REQUIRED
LABELING; Labeling	SUPPL	48	AP	2017-02-23	901 REQUIRED
LABELING; Labeling	SUPPL	49	AP	2017-02-23	STANDARD
LABELING; Labeling	SUPPL	50	AP	2018-03-27	STANDARD
LABELING; Labeling	SUPPL	51	AP	2020-10-23	STANDARD
LABELING; Labeling	SUPPL	52	AP	2021-03-04	STANDARD
LABELING; Labeling	SUPPL	53	AP	2020-04-21	901 REQUIRED
LABELING; Labeling	SUPPL	54	AP	2021-09-20	901 REQUIRED

Submissions Property Types

SUPPL	3	Null	0
SUPPL	6	Null	0
SUPPL	12	Null	7
SUPPL	22	Null	7
SUPPL	23	Null	6
SUPPL	25	Null	7
SUPPL	27	Null	7
SUPPL	28	Null	6
SUPPL	29	Null	6
SUPPL	31	Null	7
SUPPL	32	Null	6
SUPPL	33	Null	6
SUPPL	34	Null	6
SUPPL	35	Null	7
SUPPL	36	Null	15
SUPPL	37	Null	6
SUPPL	38	Null	6
SUPPL	39	Null	6
SUPPL	40	Null	7
SUPPL	41	Null	15
SUPPL	42	Null	6
SUPPL	43	Null	0
SUPPL	45	Null	7
SUPPL	46	Null	7
SUPPL	47	Null	15
SUPPL	48	Null	6
SUPPL	49	Null	6
SUPPL	50	Null	7
SUPPL	51	Null	7
SUPPL	52	Null	15
SUPPL	53	Null	6
SUPPL	54	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB
004	Prescription	AB
005	Prescription	AB

CDER Filings

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(
    [0] => Array
        (
            [ApplNo] => 21520
            [companyName] => 
            [docInserts] => ["",""]
            [products] => []
            [labels] => 
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            [supplements] => 
            [actionDate] => 0000-00-00
        )

)

NDA 021520

LILLY

FDA Drug Application

Application #021520

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

TE Codes

CDER Filings