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FDA NDA · NDA020990

SERTRALINE HYDROCHLORIDE

Sponsor: VIATRIS

APPLICATION
NDA020990
TYPE
NDA
ORIGINAL APPROVAL
1999-12-07
LATEST ACTION
2023-08-18
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription

Products

ZOLOFT · ReferencePrescription
SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML · CONCENTRATE · ORAL

Approval history

2023-08-18Labeling · Supplement 62 · standard — Label ↗AP
2023-01-25Labeling · Supplement 59 · standard — Letter ↗AP
2021-09-20Labeling · Supplement 57 · 901 required — Letter ↗AP
2017-12-08Labeling · Supplement 50 · standard — Label ↗AP
2017-12-08Labeling · Supplement 49 · standard — Label ↗AP
2017-06-15Labeling · Supplement 46 · standard — Label ↗AP
2016-12-23Labeling · Supplement 44 · standard — Label ↗AP
2016-12-23Labeling · Supplement 45 · 901 required — Label ↗AP
2016-12-23Labeling · Supplement 35 · standard — Label ↗AP
2014-09-12Labeling · Supplement 43 · standard — Label ↗AP
2014-07-03Labeling · Supplement 41 · standard — Letter ↗AP
2014-07-03Labeling · Supplement 39 · 901 required — Label ↗AP
2013-10-15Manufacturing (CMC) · Supplement 42 · standardAP
2013-02-01Labeling · Supplement 38 · standard — Letter ↗AP
2012-12-18Labeling · Supplement 34 · standard — Letter ↗AP
2012-12-18Labeling · Supplement 40 · standard — Label ↗AP
2011-08-19Labeling · Supplement 33 · standard — Label ↗AP
2011-08-19Labeling · Supplement 36 · standard — Letter ↗AP
2011-08-19Labeling · Supplement 37 · standard — Label ↗AP
2009-01-30Labeling · Supplement 32 · 901 required — Letter ↗AP
2008-03-06Labeling · Supplement 31 · standard — Letter ↗AP
2007-10-04Labeling · Supplement 29 · standard — Label ↗AP
2007-08-02Labeling · Supplement 27 · standard — Letter ↗AP
2007-08-02Labeling · Supplement 25 · standard — Letter ↗AP
2006-09-14Labeling · Supplement 26 · standard — Label ↗AP
2006-09-14Labeling · Supplement 24 · standard — Letter ↗AP
2006-05-04Labeling · Supplement 23 · standard — Letter ↗AP
2005-07-26Labeling · Supplement 22 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 19 · standard — Letter ↗AP
2005-02-18Labeling · Supplement 20 · standard — Label ↗AP
2004-08-19Labeling · Supplement 17 · standard — Letter ↗AP
2004-08-19Efficacy · Supplement 13 · standard — Letter ↗AP
2003-09-16Efficacy · Supplement 10 · standard — Review ↗AP
2003-02-07Efficacy · Supplement 11 · standard — Label ↗AP
2002-09-20Efficacy · Supplement 4 · standard — Letter ↗AP
2002-09-20Efficacy · Supplement 2 · standard — Letter ↗AP
2002-09-18Labeling · Supplement 9 · standard — Letter ↗AP
2002-05-16Efficacy · Supplement 7 · standard — Letter ↗AP
2001-10-12Efficacy · Supplement 1 · standard — Letter ↗AP
2001-08-06Efficacy · Supplement 3 · standard — Review ↗AP
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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