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

Marketedupdated 3mo 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
17y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Mar 14, 2011
approval
15y 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
10y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Mar 14, 2016
approval
10y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Mar 14, 2016
approval
10y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Mar 14, 2016
approval
10y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Feb 21, 2020
approval
6y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Feb 21, 2020
approval
6y ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Feb 21, 2020
approval
6y 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
9mo ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jan 20, 2026
approval
7mo ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jan 20, 2026
approval
7mo ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jan 28, 2026
approval
$AMRX18.15+5.10%
7mo ago
SERTRALINE HYDROCHLORIDE — FDA approval
SERTRALINE HYDROCHLORIDE
→
Jan 29, 2026
approval
7mo 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(1)

  • 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 · 3mo 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 32m ago
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