← FDA DRUG APPROVALS

FDA NDA · NDA021299

PEXEVA

Sponsor: SEBELA IRELAND LTD

APPLICATION
NDA021299
TYPE
NDA
ORIGINAL APPROVAL
2003-07-03
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PEXEVA · ReferenceDiscontinued
PAROXETINE MESYLATE EQ 40MG BASE · TABLET · ORAL
PEXEVA · ReferenceDiscontinued
PAROXETINE MESYLATE EQ 20MG BASE · TABLET · ORAL
PEXEVA · ReferenceDiscontinued
PAROXETINE MESYLATE EQ 30MG BASE · TABLET · ORAL
PEXEVA · ReferenceDiscontinued
PAROXETINE MESYLATE EQ 10MG BASE · TABLET · ORAL

Approval history

2023-08-18Labeling · Supplement 35 · standard — Label ↗AP
2023-08-18Labeling · Supplement 38 · standard — Medication Guide ↗AP
2021-09-20Labeling · Supplement 37 · 901 required — Letter ↗AP
2020-12-31Labeling · Supplement 31 · standard — Label ↗AP
2017-01-04Labeling · Supplement 33 · 901 required — Label ↗AP
2014-07-18Labeling · Supplement 32 · 901 required — Letter ↗AP
2012-12-18Labeling · Supplement 28 · standard — Letter ↗AP
2012-12-18Labeling · Supplement 29 · standard — Letter ↗AP
2012-12-18Labeling · Supplement 27 · standard — Letter ↗AP
2012-11-26Manufacturing (CMC) · Supplement 30 · standardAP
2011-04-28Labeling · Supplement 24 · standard — Letter ↗AP
2010-01-29Labeling · Supplement 22 · standard — Label ↗AP
2009-01-30Labeling · Supplement 23 · standard — Letter ↗AP
2008-03-06Labeling · Supplement 21 · standard — Letter ↗AP
2007-10-05Labeling · Supplement 20 · standard — Letter ↗AP
2007-08-03Labeling · Supplement 19 · standard — Label ↗AP
2006-12-09Efficacy · Supplement 18 · standard — Letter ↗AP
2006-12-09Efficacy · Supplement 16 · standard — Letter ↗AP
2006-12-09Efficacy · Supplement 17 · standard — Label ↗AP
2005-01-12Labeling · Supplement 13 · standard — Letter ↗AP
2004-08-30Labeling · Supplement 7 · standard — Letter ↗AP
2003-08-21Labeling · Supplement 1 · standard — Review ↗AP
2003-07-03Type 2 - New Active Ingredient · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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