APPLICATION
ANDA077663
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2026-05-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
Approval history
2026-05-07Labeling · Supplement 9 · standardAP
2022-08-30Labeling · Supplement 8 · standardAP
2020-02-21Labeling · Supplement 7 · standardAP
2009-08-31Labeling · Supplement 6AP
2008-08-25Labeling · Supplement 4AP
2008-08-25Labeling · Supplement 3AP
2008-02-15Labeling · 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.
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