APPLICATION
ANDA076882
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2020-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SERTRALINE HYDROCHLORIDEPrescription
SERTRALINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEPrescription
SERTRALINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEPrescription
SERTRALINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
Approval history
2020-02-21Labeling · Supplement 18 · standardAP
2020-02-21Labeling · Supplement 19 · standardAP
2020-02-21Labeling · Supplement 17 · standardAP
2015-06-04Labeling · Supplement 16 · standardAP
2014-10-27Labeling · Supplement 14 · standardAP
2014-10-27Labeling · Supplement 15 · standardAP
2014-10-27Labeling · Supplement 13 · standardAP
2012-07-31Labeling · Supplement 12AP
2011-01-04Labeling · Supplement 11AP
2008-08-08Labeling · Supplement 9AP
2008-08-08Labeling · Supplement 6AP
2008-05-06Labeling · Supplement 3AP
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.