← FDA DRUG APPROVALS

FDA NDA · NDA020031

PAXIL

paroxetine hydrochloride

Sponsor: APOTEX

APPLICATION
NDA020031
TYPE
NDA
ORIGINAL APPROVAL
1992-12-29
LATEST ACTION
2024-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

PAXILDiscontinued
PAROXETINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
PAXIL · ReferencePrescription
PAROXETINE HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
PAXIL · ReferencePrescription
PAROXETINE HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
PAXIL · ReferencePrescription
PAROXETINE HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
PAXIL · ReferencePrescription
PAROXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL

Approval history

2024-11-26Labeling · Supplement 83 · standardLabelAP
2023-08-18Labeling · Supplement 82 · standardLabelAP
2021-09-20Labeling · Supplement 79 · 901 requiredLetterAP
2021-02-06Labeling · Supplement 77 · standardLetterAP
2017-01-04Labeling · Supplement 74 · 901 requiredLabelAP
2014-07-18Labeling · Supplement 71 · 901 requiredLabelAP
2012-12-18Labeling · Supplement 67 · standardLetterAP
2012-04-10Labeling · Supplement 68 · standardLetterAP
2011-07-08Labeling · Supplement 66 · standardLetterAP
2011-07-08Labeling · Supplement 58 · standardLetterAP
2011-03-21Labeling · Supplement 62 · standardLabelAP
2011-03-21Labeling · Supplement 69 · standardLetterAP
2011-03-21Labeling · Supplement 65 · unknownLabelAP
2010-10-27Labeling · Supplement 63 · standardLetterAP
2009-08-07Labeling · Supplement 59 · standardLabelAP
2009-01-30Labeling · Supplement 61 · standardLetterAP
2008-10-31Labeling · Supplement 60 · standardLabelAP
2007-08-02Labeling · Supplement 53 · standardLabelAP
2006-08-22Labeling · Supplement 54 · standardLetterAP
2006-08-22Labeling · Supplement 49 · standardLetterAP
2006-08-22Labeling · Supplement 55 · standardLetterAP
2006-03-09Labeling · Supplement 46 · standardLetterAP
2006-02-06Labeling · Supplement 48 · standardLetterAP
2006-02-06Labeling · Supplement 52 · standardReviewAP
2006-02-06Labeling · Supplement 51 · standardLetterAP
2005-07-13Labeling · Supplement 42 · standardLetterAP
2005-01-12Labeling · Supplement 45 · standardLabelAP
2004-05-21Labeling · Supplement 43 · standardLetterAP
2004-04-08Labeling · Supplement 40 · standardLetterAP
2004-04-08Labeling · Supplement 39 · standardLetterAP
2002-10-02Efficacy · Supplement 35 · standardLetterAP
2001-12-14Efficacy · Supplement 29 · standardLetterAP
2001-05-22Manufacturing (CMC) · Supplement 33 · standardAP
2001-04-30Manufacturing (CMC) · Supplement 34 · standardAP
2001-04-30Manufacturing (CMC) · Supplement 32 · standardAP
2001-04-13Efficacy · Supplement 26 · standardLabelAP
2001-02-15Labeling · Supplement 31 · standardReviewAP
2000-09-28Labeling · Supplement 30 · standardReviewAP
2000-09-21Manufacturing (CMC) · Supplement 28 · standardReviewAP
2000-09-20Manufacturing (CMC) · Supplement 27 · standardReviewAP
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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