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FDA ANDA · ANDA077584
PAROXETINE
paroxetine hydrochloride
Sponsor: ZYDUS PHARMS USA
APPLICATION
ANDA077584
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-07
LATEST ACTION
2025-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 40MG BASE · TABLET · ORAL
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 20MG BASE · TABLET · ORAL
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 30MG BASE · TABLET · ORAL
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2025-02-28Labeling · Supplement 38 · standardAP
2024-06-12Labeling · Supplement 37 · standardAP
2022-02-25Labeling · Supplement 35 · standardAP
2022-02-25Labeling · Supplement 34 · standardAP
2020-03-19Labeling · Supplement 29 · standardAP
2020-03-19Labeling · Supplement 28 · standardAP
2015-01-19Labeling · Supplement 27 · standardAP
2014-11-26Manufacturing (CMC) · Supplement 23AP
2013-08-19Labeling · Supplement 22 · standardAP
2013-08-19Labeling · Supplement 25 · standardAP
2012-07-31Labeling · Supplement 19AP
2011-07-27Labeling · Supplement 18AP
2011-03-04Labeling · Supplement 17AP
2011-01-30Manufacturing (CMC) · Supplement 13AP
2010-10-15Labeling · Supplement 15AP
2009-04-29Labeling · Supplement 10AP
2009-04-29Labeling · Supplement 9AP
2008-05-29Labeling · Supplement 7AP
2008-05-20Labeling · Supplement 2AP
2007-03-07OriginalAP
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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