← FDA DRUG APPROVALS

FDA NDA · NDA021992

PRISTIQ EXTENDED-RELEASE

desvenlafaxine succinate

Sponsor: PF PRISM CV

APPLICATION
NDA021992
TYPE
NDA
ORIGINAL APPROVAL
2008-02-29
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

PRISTIQ · ReferencePrescription
DESVENLAFAXINE SUCCINATE EQ 100MG BASE · TABLET, EXTENDED RELEASE · ORAL
PRISTIQ · ReferencePrescription
DESVENLAFAXINE SUCCINATE EQ 25MG BASE · TABLET, EXTENDED RELEASE · ORAL
PRISTIQ · ReferencePrescription
DESVENLAFAXINE SUCCINATE EQ 50MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2023-08-18Labeling · Supplement 51 · standard — Label ↗AP
2021-11-10Labeling · Supplement 47 · standard — Letter ↗AP
2021-09-20Labeling · Supplement 48 · 901 required — Letter ↗AP
2018-02-06Efficacy · Supplement 42 · standard — Label ↗AP
2017-12-19Labeling · Supplement 46 · 901 required — Label ↗AP
2017-01-04Labeling · Supplement 44 · 901 required — Label ↗AP
2016-08-26Labeling · Supplement 43 · 901 required — Letter ↗AP
2016-03-16Manufacturing (CMC) · Supplement 41 · standardAP
2014-08-20Type 1 - New Molecular Entity · Supplement 39 · standard — Label ↗AP
2014-07-17Labeling · Supplement 40 · 901 required — Letter ↗AP
2013-12-23Labeling · Supplement 37 · standard — Label ↗AP
2013-12-10Labeling · Supplement 31 · standard — Label ↗AP
2013-04-19Manufacturing (CMC) · Supplement 35 · standardAP
2013-02-14Labeling · Supplement 36 · standard — Label ↗AP
2013-02-14Efficacy · Supplement 33 · standard — Letter ↗AP
2012-12-07Labeling · Supplement 34 · standard — Letter ↗AP
2012-03-07Labeling · Supplement 30 · standard — Label ↗AP
2011-04-11Labeling · Supplement 22 · standard — Letter ↗AP
2011-03-04Labeling · Supplement 21 · standard — Letter ↗AP
2011-01-31Labeling · Supplement 20 · standard — Label ↗AP
2010-12-29Labeling · Supplement 19 · standard — Letter ↗AP
2010-10-18Labeling · Supplement 13 · unknown — Label ↗AP
2010-09-08Labeling · Supplement 17 · standard — Letter ↗AP
2010-07-09Labeling · Supplement 15 · unknown — Label ↗AP
2010-02-16Labeling · Supplement 11 · unknown — Label ↗AP
2009-11-09Labeling · Supplement 8 · unknown — Letter ↗AP
2009-11-09Labeling · Supplement 9 · unknown — Label ↗AP
2009-08-31Labeling · Supplement 6 · standard — Label ↗AP
2009-08-31Labeling · Supplement 7 · standard — Letter ↗AP
2009-08-31Labeling · Supplement 1 · standard — Label ↗AP
2009-04-23Manufacturing (CMC) · Supplement 5 — Label ↗AP
2009-01-30Labeling · Supplement 4 · standard — Letter ↗AP
2008-02-29Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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