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FDA NDA · NDA020936

PAROXETINE HYDROCHLORIDE

Sponsor: APOTEX

APPLICATION
NDA020936
TYPE
NDA
ORIGINAL APPROVAL
1999-02-16
LATEST ACTION
2024-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

PAXIL CR · ReferencePrescription
PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
PAXIL CR · ReferencePrescription
PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
PAXIL CR · ReferencePrescription
PAROXETINE HYDROCHLORIDE EQ 25MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-02-23Labeling · Supplement 65 · standard — Letter ↗AP
2023-08-18Labeling · Supplement 57 · standard — Label ↗AP
2023-08-18Labeling · Supplement 64 · standard — Label ↗AP
2021-09-20Labeling · Supplement 60 · 901 required — Letter ↗AP
2019-09-11Labeling · Supplement 47 · standard — Letter ↗AP
2017-01-04Labeling · Supplement 53 · 901 required — Label ↗AP
2014-07-18Labeling · Supplement 49 · 901 required — Letter ↗AP
2012-12-18Labeling · Supplement 45 · standard — Letter ↗AP
2012-04-10Labeling · Supplement 46 · standard — Label ↗AP
2011-07-08Labeling · Supplement 44 · standard — Letter ↗AP
2011-07-08Labeling · Supplement 34 · standard — Letter ↗AP
2011-03-21Labeling · Supplement 43 · unknown — Letter ↗AP
2011-03-21Labeling · Supplement 40 · standard — Label ↗AP
2010-10-27Labeling · Supplement 41 · standard — Letter ↗AP
2009-08-07Labeling · Supplement 35 · standard — Letter ↗AP
2009-07-17Manufacturing (CMC) · Supplement 39 · standard — Letter ↗AP
2009-01-30Labeling · Supplement 38 · standard — Letter ↗AP
2008-10-31Labeling · Supplement 37 · standard — Letter ↗AP
2007-08-02Labeling · Supplement 29 · standard — Label ↗AP
2006-08-22Labeling · Supplement 31 · standard — Letter ↗AP
2006-08-22Labeling · Supplement 23 · standard — Letter ↗AP
2006-08-22Labeling · Supplement 30 · standard — Letter ↗AP
2006-03-09Labeling · Supplement 21 · standard — Letter ↗AP
2006-02-06Labeling · Supplement 27 · standard — Letter ↗AP
2006-02-06Labeling · Supplement 26 · standard — Letter ↗AP
2006-02-06Labeling · Supplement 22 · standard — Letter ↗AP
2005-07-13Labeling · Supplement 18 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 20 · standard — Letter ↗AP
2004-05-21Labeling · Supplement 19 · standard — Letter ↗AP
2004-01-27Efficacy · Supplement 13 · standard — Letter ↗AP
2003-10-16Efficacy · Supplement 12 · standard — Letter ↗AP
2003-08-28Efficacy · Supplement 11 · standard — Review ↗AP
2002-07-22Manufacturing (CMC) · Supplement 9 · standardAP
2002-02-12Labeling · Supplement 8 · standard — Review ↗AP
2001-04-30Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
2001-04-30Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
2000-12-06Manufacturing (CMC) · Supplement 5 · standardAP
2000-09-21Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
2000-08-17Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
2000-07-18Manufacturing (CMC) · Supplement 4 · 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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