APPLICATION
ANDA077206
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2025-11-20
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
2025-11-20Manufacturing (CMC) · Supplement 50 · unknownAP
2024-02-01Labeling · Supplement 41 · standardAP
2023-07-26Labeling · Supplement 38 · standardAP
2023-07-26Labeling · Supplement 39 · standardAP
2020-02-21Labeling · Supplement 31 · standardAP
2020-02-21Labeling · Supplement 30 · standardAP
2020-02-21Labeling · Supplement 29 · standardAP
2016-03-14Labeling · Supplement 1AP
2016-03-14Labeling · Supplement 24 · standardAP
2016-03-14Manufacturing (CMC) · Supplement 16AP
2016-03-14Labeling · Supplement 20 · standardAP
2012-05-21Labeling · Supplement 19AP
2011-09-29Labeling · Supplement 17AP
2011-03-14Labeling · Supplement 14AP
2009-02-25Labeling · Supplement 13AP
2008-09-15Labeling · Supplement 9AP
2008-06-25Labeling · Supplement 4AP
2007-12-26Labeling · Supplement 6AP
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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