NDA 021992

PF PRISM CV

FDA Drug Application

Application #021992

Documents

• Letter: 2008-03-05
• Letter: 2009-11-24
• Letter: 2010-01-25
• Letter: 2010-02-22
• Letter: 2010-09-09
• Letter: 2011-01-25
• Letter: 2011-03-07
• Letter: 2011-04-13
• Letter: 2013-12-13
• Letter: 2013-02-19
• Letter: 2012-12-11
• Letter: 2013-03-15
• Letter: 2014-07-21
• Label: 2009-11-05
• Label: 2009-09-18
• Label: 2010-10-18
• Label: 2010-07-12
• Label: 2010-09-10
• Label: 2011-01-10
• Label: 2011-01-31
• Label: 2011-03-07
• Label: 2011-04-11
• Letter: 2009-11-24
• Letter: 2009-02-03
• Letter: 2009-04-29
• Letter: 2009-11-24
• Letter: 2010-01-25
• Letter: 2010-10-20
• Letter: 2010-07-14
• Letter: 2011-02-03
• Letter: 2012-03-12
• Letter: 2013-12-24
• Letter: 2014-11-14
• Label: 2008-03-05
• Label: 2009-02-04
• Label: 2009-04-28
• Label: 2009-09-18
• Label: 2009-11-17
• Label: 2010-02-17
• Label: 2012-03-09
• Label: 2013-12-11
• Label: 2013-02-20
• Label: 2012-12-10
• Label: 2013-02-20
• Label: 2013-12-24
• Label: 2014-11-17
• Label: 2014-07-29
• Review: 2008-06-13
• Letter: 2016-08-26
• Label: 2016-08-26
• Label: 2017-01-06
• Label: 2017-12-21
• Medication Guide: 2017-12-21
• Letter: 2017-12-27
• Label: 2018-02-06
• Letter: 2018-02-08
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Clinical Pharmacology Addendum: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2021-09-21
• Label: 2021-09-21
• Medication Guide: 2021-09-21
• Letter: 2021-11-12
• Label: 2021-11-12
• Medication Guide: 2021-11-12

Application Sponsors

NDA 021992

PF PRISM CV

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	EQ 50MG BASE	1	PRISTIQ	DESVENLAFAXINE SUCCINATE
002	TABLET, EXTENDED RELEASE;ORAL	EQ 100MG BASE	1	PRISTIQ	DESVENLAFAXINE SUCCINATE
003	TABLET, EXTENDED RELEASE;ORAL	EQ 25MG BASE	1	PRISTIQ	DESVENLAFAXINE SUCCINATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2008-02-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2009-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2009-04-23	N/A
LABELING; Labeling	SUPPL	6	AP	2009-08-31	STANDARD
LABELING; Labeling	SUPPL	7	AP	2009-08-31	STANDARD
LABELING; Labeling	SUPPL	8	AP	2009-11-09	UNKNOWN
LABELING; Labeling	SUPPL	9	AP	2009-11-09	UNKNOWN
LABELING; Labeling	SUPPL	11	AP	2010-02-16	UNKNOWN
LABELING; Labeling	SUPPL	13	AP	2010-10-18	UNKNOWN
LABELING; Labeling	SUPPL	15	AP	2010-07-09	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2010-09-08	STANDARD
LABELING; Labeling	SUPPL	19	AP	2010-12-29	STANDARD
LABELING; Labeling	SUPPL	20	AP	2011-01-31	STANDARD
LABELING; Labeling	SUPPL	21	AP	2011-03-04	STANDARD
LABELING; Labeling	SUPPL	22	AP	2011-04-11	STANDARD
LABELING; Labeling	SUPPL	30	AP	2012-03-07	STANDARD
LABELING; Labeling	SUPPL	31	AP	2013-12-10	STANDARD
EFFICACY; Efficacy	SUPPL	33	AP	2013-02-14	STANDARD
LABELING; Labeling	SUPPL	34	AP	2012-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	2013-04-19	STANDARD
LABELING; Labeling	SUPPL	36	AP	2013-02-14	STANDARD
LABELING; Labeling	SUPPL	37	AP	2013-12-23	STANDARD
TYPE 1; Type 1 - New Molecular Entity	SUPPL	39	AP	2014-08-20	STANDARD
LABELING; Labeling	SUPPL	40	AP	2014-07-17	901 REQUIRED
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	2016-03-16	STANDARD
EFFICACY; Efficacy	SUPPL	42	AP	2018-02-06	STANDARD
LABELING; Labeling	SUPPL	43	AP	2016-08-26	901 REQUIRED
LABELING; Labeling	SUPPL	44	AP	2017-01-04	901 REQUIRED
LABELING; Labeling	SUPPL	46	AP	2017-12-19	901 REQUIRED
LABELING; Labeling	SUPPL	47	AP	2021-11-10	STANDARD
LABELING; Labeling	SUPPL	48	AP	2021-09-20	901 REQUIRED

Submissions Property Types

SUPPL	1	Null	6
SUPPL	6	Null	7
SUPPL	7	Null	6
SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	11	Null	7
SUPPL	13	Null	7
SUPPL	15	Null	7
SUPPL	17	Null	6
SUPPL	19	Null	7
SUPPL	20	Null	6
SUPPL	21	Null	6
SUPPL	22	Null	6
SUPPL	30	Null	6
SUPPL	31	Null	6
SUPPL	33	Null	7
SUPPL	34	Null	7
SUPPL	35	Null	0
SUPPL	36	Null	15
SUPPL	37	Null	15
SUPPL	39	Null	0
SUPPL	40	Null	15
SUPPL	41	Null	0
SUPPL	42	Null	6
SUPPL	43	Null	15
SUPPL	44	Null	6
SUPPL	46	Null	6
SUPPL	47	Null	6
SUPPL	48	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PF PRISM CV

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(
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            [companyName] => PF PRISM CV
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            [supplements] => 
            [actionDate] => 2021-11-10
        )

)