APPLICATION
ANDA077162
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2020-02-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval), Discontinued
Products
SERTRALINE HYDROCHLORIDENone (Tentative Approval)
SERTRALINE HYDROCHLORIDE 200MG · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDENone (Tentative Approval)
SERTRALINE HYDROCHLORIDE 150MG · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
Approval history
2020-02-14Labeling · Supplement 9 · standardAP
2020-02-14Labeling · Supplement 7 · standardAP
2020-02-14Labeling · Supplement 8 · standardAP
2016-02-01Labeling · Supplement 5 · standardAP
2014-11-10Labeling · Supplement 4 · standardAP
2008-05-07Labeling · Supplement 3AP
2007-07-12Labeling · Supplement 1AP
2007-07-12Labeling · 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.