APPLICATION
ANDA077864
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-10
LATEST ACTION
2025-08-18
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
2025-08-18Labeling · Supplement 4 · standardAP
2025-08-18Labeling · Supplement 5 · standardAP
2025-08-18Labeling · Supplement 3 · standardAP
2020-02-21Labeling · Supplement 2 · standardAP
2014-02-10Labeling · Supplement 1 · standardAP
2009-08-10OriginalAP
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.