APPLICATION
ANDA077299
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2022-08-30
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
2022-08-30Labeling · Supplement 5 · standardAP
2020-02-21Labeling · Supplement 4 · standardAP
2015-11-02Labeling · Supplement 3AP
2008-01-09Labeling · 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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