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FDA NDA · NDA020710

PAXIL

Sponsor: APOTEX

APPLICATION
NDA020710
TYPE
NDA
ORIGINAL APPROVAL
1997-06-25
LATEST ACTION
2024-11-26
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

PAXIL · ReferenceDiscontinued
PAROXETINE HYDROCHLORIDE EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2024-11-26Labeling · Supplement 51 · standard — Label ↗AP
2023-08-18Labeling · Supplement 50 · standardAP
2021-09-20Labeling · Supplement 47 · 901 required — Letter ↗AP
2021-02-06Labeling · Supplement 45 · standard — Letter ↗AP
2017-01-04Labeling · Supplement 38 · 901 required — Label ↗AP
2014-07-18Labeling · Supplement 35 · 901 required — Label ↗AP
2012-12-18Labeling · Supplement 31 · standard — Label ↗AP
2012-04-10Labeling · Supplement 32 · standard — Label ↗AP
2011-07-08Labeling · Supplement 30 · standard — Label ↗AP
2011-07-08Labeling · Supplement 22 · standard — Label ↗AP
2011-03-21Labeling · Supplement 26 · standard — Letter ↗AP
2011-03-21Labeling · Supplement 29 · unknown — Letter ↗AP
2011-03-21Labeling · Supplement 33 · standard — Label ↗AP
2010-10-27Labeling · Supplement 27 · standard — Label ↗AP
2009-08-07Labeling · Supplement 23 · standard — Letter ↗AP
2009-01-30Labeling · Supplement 25 · standard — Letter ↗AP
2008-10-31Labeling · Supplement 24 · standard — Letter ↗AP
2007-08-02Labeling · Supplement 17 · standard — Label ↗AP
2006-08-22Labeling · Supplement 18 · standard — Letter ↗AP
2006-08-22Labeling · Supplement 19 · standard — Letter ↗AP
2006-02-06Labeling · Supplement 15 · standard — Letter ↗AP
2006-02-06Labeling · Supplement 16 · standard — Letter ↗AP
2001-11-08Manufacturing (CMC) · Supplement 12 · standardAP
2001-04-30Manufacturing (CMC) · Supplement 11 · standard — Review ↗AP
2001-04-30Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
2001-02-15Labeling · Supplement 9 · standardAP
2000-09-28Labeling · Supplement 8 · standardAP
2000-09-21Manufacturing (CMC) · Supplement 6 · standardAP
2000-07-18Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
2000-06-27Manufacturing (CMC) · Supplement 5 · standardAP
1999-02-23Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
1998-02-20Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
1997-11-06Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1997-06-25Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗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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