APPLICATION
ANDA077765
TYPE
ANDA
ORIGINAL APPROVAL
2007-02-06
LATEST ACTION
2020-02-21
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
2020-02-21Labeling · Supplement 17 · standardAP
2015-12-17Labeling · Supplement 16 · standardAP
2015-12-17Labeling · Supplement 15 · standardAP
2012-04-24Labeling · Supplement 13AP
2011-11-14Manufacturing (CMC) · Supplement 10AP
2010-04-26Labeling · Supplement 9AP
2009-05-28Labeling · Supplement 8AP
2009-05-28Labeling · Supplement 6AP
2008-02-14Labeling · Supplement 2AP
2008-02-14Labeling · Supplement 1AP
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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