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  1. pharmadog
  2. ›drugs
  3. ›SERTRALINE HYDROCHLORIDE
drug · small molecule
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SERTRALINE HYDROCHLORIDE

Marketedupdated 5mo ago
/ SUR-trə-leen /
by $AMRX Amneal Pharmaceuticals, Inc.🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 7
  • tagApproval48 co-mentions · 24 sources
  • drugZoloft25 co-mentions · 25 sources
  • tagSmall Molecule24 co-mentions · 24 sources
  • companyAurobindo Pharma Ltd19 co-mentions · 19 sources
  • companyZydus Lifesciences Ltd1 co-mentions · 1 sources
  • companyNovitium Pharma LLC1 co-mentions · 1 sources
  • tagRecall1 co-mentions · 1 sources

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 5 approved and 3 investigational indications.

indications

investigational
Major Depression

targets

Sodium-dependent serotonin transporter

all catalysts(23)

approval · 23
Feb 6, 2007
approval
20y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Dec 26, 2007
approval
19y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jun 25, 2008
approval
18y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Sep 15, 2008
approval
18y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Feb 25, 2009
approval
18y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Mar 14, 2011
approval
16y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Sep 29, 2011
approval
15y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
May 21, 2012
approval
14y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Mar 14, 2016
approval
11y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Mar 14, 2016
approval
11y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Mar 14, 2016
approval
11y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Mar 14, 2016
approval
11y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Feb 21, 2020
approval
7y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Feb 21, 2020
approval
7y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Feb 21, 2020
approval
7y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jul 26, 2023
approval
3y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jul 26, 2023
approval
3y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Feb 1, 2024
approval
3y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Nov 20, 2025
approval
10mo ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jan 20, 2026
approval
8mo ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jan 20, 2026
approval
8mo ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jan 28, 2026
approval
$AMRX20.14-0.30%
8mo ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jan 29, 2026
approval
8mo ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
view all 23 catalysts →

Trials studying SERTRALINE HYDROCHLORIDE

  • phase1Sertraline Hydrochloride 100 mg Tablets, Fedcompletedn=18
  • phase1Sertraline Hydrochloride 100 mg Tablets, Fastingcompletedn=24
  • phase1Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mgcompletedn=49
  • phase1Food Study of Sertraline Hydrochloride Tablets 100 mg and Zoloft® Tablets 100 mgcompletedn=21

Patent cliff

source: FDA Orange Book

FDA exclusivities (2)

  • Jan 18, 2026CGTCGT
  • Jan 18, 2026CGTCGT

News(3)

  • Xenon tumbles on voluntary psychiatry hold, but analysts confident in $2B epilepsy opportunity
    As Xenon Pharmaceuticals announced that azetukalner has reached the FDA for focal seizures, the company also disclosed the emergence of psychosis adverse events in psychiatric trials of the drug, t…
    biospace · 12d ago
  • Xenon pauses phase 3 depression trials after psychosis events
    The company has voluntarily stopped enrolling new patients in the studies in response to reports of mostly mild or moderate adverse events.
    fiercebiotech · 12d ago
  • STAT+: Pharmalittle: We’re reading about RFK Jr. targeting antidepressants, J&J pushing an IBD drug, and more
    HHS Secretary Robert F. Kennedy Jr. announced initiatives to rein in prescribing of SSRIs, the most widely used antidepressants
    stat · 4mo ago
brand
SERTRALINE HYDROCHLORIDE
trade names
Aremis, Besitron, Lustral, Sertraline hydrochloride, Zoloft
generic
SERTRALINE HYDROCHLORIDE
MOA
Serotonin transporter inhibitor
phase
marketed
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 2h ago
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