APPLICATION
ANDA091427
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-14
LATEST ACTION
2026-04-06
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
PAROXETINE HYDROCHLORIDEPrescription
PAROXETINE HYDROCHLORIDE EQ 37.5MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-04-06Labeling · Supplement 14 · standardAP
2026-04-06Labeling · Supplement 15 · standardAP
2021-05-04Labeling · Supplement 9 · standardAP
2021-05-04Labeling · Supplement 11 · standardAP
2015-07-15Labeling · Supplement 6 · standardAP
2013-12-27Labeling · Supplement 5 · standardAP
2011-12-27Labeling · Supplement 2AP
2011-06-24Labeling · Supplement 1AP
2011-04-14OriginalAP
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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