← FDA DRUG APPROVALS

FDA NDA · NDA019839

ZOLOFT

sertraline hydrochloride

Sponsor: VIATRIS

APPLICATION
NDA019839
TYPE
NDA
ORIGINAL APPROVAL
1991-12-30
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

ZOLOFT · ReferenceDiscontinued
SERTRALINE HYDROCHLORIDE EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZOLOFT · ReferencePrescription
SERTRALINE HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
ZOLOFT · ReferencePrescription
SERTRALINE HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL
ZOLOFT · ReferenceDiscontinued
SERTRALINE HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZOLOFT · ReferencePrescription
SERTRALINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL

Approval history

2023-08-18Labeling · Supplement 108 · standardLabelAP
2023-01-25Labeling · Supplement 102 · standardLetterAP
2021-09-20Labeling · Supplement 100 · 901 requiredLetterAP
2017-12-08Labeling · Supplement 93 · standardLabelAP
2017-12-08Labeling · Supplement 91 · standardLabelAP
2017-06-15Labeling · Supplement 88 · standardLabelAP
2016-12-23Labeling · Supplement 86 · standardLabelAP
2016-12-23Labeling · Supplement 74 · standardLabelAP
2016-12-23Labeling · Supplement 87 · 901 requiredLabelAP
2014-09-12Labeling · Supplement 84 · standardLabelAP
2014-07-03Labeling · Supplement 83 · standardLabelAP
2014-07-03Labeling · Supplement 80 · 901 requiredLabelAP
2014-01-10Manufacturing (CMC) · Supplement 85 · standardAP
2013-09-26Manufacturing (CMC) · Supplement 82 · standardAP
2013-02-01Labeling · Supplement 79 · standardLetterAP
2012-12-18Labeling · Supplement 81 · standardLetterAP
2012-12-18Labeling · Supplement 73 · standardLetterAP
2011-08-19Labeling · Supplement 75 · standardLabelAP
2011-08-19Labeling · Supplement 76 · standardLabelAP
2011-08-19Labeling · Supplement 72 · standardLetterAP
2009-01-30Labeling · Supplement 70 · 901 requiredLabelAP
2008-03-06Labeling · Supplement 68 · standardLabelAP
2007-10-04Labeling · Supplement 65 · standardLetterAP
2007-08-02Labeling · Supplement 59 · standardLetterAP
2007-08-02Labeling · Supplement 63 · standardLetterAP
2007-08-02Labeling · Supplement 64 · standardLetterAP
2006-09-14Labeling · Supplement 58 · standardLetterAP
2006-09-14Labeling · Supplement 60 · standardLabelAP
2006-05-04Labeling · Supplement 57 · standardLetterAP
2005-07-26Labeling · Supplement 55 · standardLetterAP
2005-02-18Labeling · Supplement 53 · standardLabelAP
2005-02-18Labeling · Supplement 54 · standardLetterAP
2004-08-19Efficacy · Supplement 47 · standardLetterAP
2004-08-19Labeling · Supplement 50 · standardLabelAP
2003-09-16Efficacy · Supplement 44 · standardPediatric Medical ReviewAP
2003-02-07Efficacy · Supplement 45 · standardLabelAP
2002-09-20Efficacy · Supplement 36 · standardLetterAP
2002-09-20Efficacy · Supplement 34 · standardAP
2002-09-18Labeling · Supplement 43 · standardLetterAP
2002-05-16Efficacy · Supplement 39 · standardLetterAP
VIEW ON DRUGS@FDA ↗

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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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