APPLICATION
ANDA077345
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2026-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
Approval history
2026-06-03Labeling · Supplement 14 · standardAP
2022-08-30Labeling · Supplement 13 · standardAP
2008-11-17Labeling · Supplement 11AP
2008-04-17Labeling · Supplement 6AP
2007-09-12Labeling · Supplement 3AP
2007-06-19Labeling · Supplement 2AP
2007-02-06OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.