APPLICATION
ANDA075356
TYPE
ANDA
ORIGINAL APPROVAL
2003-07-30
LATEST ACTION
2020-07-21
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
2020-07-21Labeling · Supplement 37 · standardAP
2014-12-21Labeling · Supplement 36 · standardAP
2013-12-31Labeling · Supplement 35 · standardAP
2012-01-05Labeling · Supplement 33AP
2011-12-15Labeling · Supplement 34AP
2011-07-27Labeling · Supplement 32AP
2010-03-25Labeling · Supplement 31AP
2009-10-26Labeling · Supplement 30AP
2009-05-14Labeling · Supplement 29AP
2008-02-05Labeling · Supplement 25AP
2008-02-05Labeling · Supplement 24AP
2007-02-05Labeling · Supplement 23AP
2007-02-05Labeling · Supplement 21AP
2006-06-29Labeling · Supplement 19AP
2006-06-29Labeling · Supplement 18AP
2005-12-27Labeling · Supplement 16AP
2005-12-02Labeling · Supplement 15AP
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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