APPLICATION
ANDA076671
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2024-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
SERTRALINE HYDROCHLORIDEDiscontinued
SERTRALINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
Approval history
2024-02-05Labeling · Supplement 14 · standardAP
2024-02-05Labeling · Supplement 15 · standardAP
2019-12-13Labeling · Supplement 12 · standardAP
2012-12-21Labeling · Supplement 11AP
2010-06-25Labeling · Supplement 8AP
2009-06-25Labeling · Supplement 6AP
2009-01-06Labeling · Supplement 5AP
2008-07-16Labeling · Supplement 4AP
2008-01-09Labeling · Supplement 2AP
2008-01-09Labeling · Supplement 3AP
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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