APPLICATION
ANDA077670
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2025-01-29
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
2025-01-29Manufacturing (CMC) · Supplement 50 · unknownAP
2023-03-02Labeling · Supplement 42 · standardAP
2022-12-05Manufacturing (CMC) · Supplement 35 · unknownAP
2022-08-30Labeling · Supplement 41 · standardAP
2020-02-21Labeling · Supplement 31 · standardAP
2020-02-21Labeling · Supplement 29 · standardAP
2020-02-21Labeling · Supplement 27 · standardAP
2015-12-23Labeling · Supplement 25 · standardAP
2014-10-27Labeling · Supplement 21 · standardAP
2014-10-27Labeling · Supplement 24 · standardAP
2013-12-16Labeling · Supplement 16 · standardAP
2013-12-16Labeling · Supplement 20 · standardAP
2009-06-18Labeling · Supplement 9AP
2008-07-02Labeling · Supplement 4AP
2007-10-25Labeling · 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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