APPLICATION
ANDA077873
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-29
LATEST ACTION
2026-04-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 12.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 25MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-04-06Labeling · Supplement 29 · standardAP
2026-04-06Labeling · Supplement 28 · standardAP
2021-05-04Labeling · Supplement 25 · standardAP
2021-05-04Labeling · Supplement 23 · standardAP
2015-07-15Labeling · Supplement 21 · standardAP
2013-12-27Labeling · Supplement 20 · standardAP
2011-12-27Labeling · Supplement 19AP
2011-07-27Labeling · Supplement 15AP
2011-06-24Labeling · Supplement 17AP
2010-08-18Labeling · Supplement 14AP
2010-07-02Labeling · Supplement 11AP
2009-07-22Labeling · Supplement 5AP
2008-11-17Labeling · Supplement 3AP
2008-03-26Labeling · Supplement 2AP
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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