Tools / Drug approvals and letters / Drugs Sertraline Hydrochloride Sold as Zoloft, Sertraline Hydrochloride. Every FDA application for this active ingredient: 3 branded and 36 generic.
As of Nov 15, 2026, FDA lists 39 applications for Sertraline Hydrochloride (sold as Zoloft, Sertraline Hydrochloride), first approved Dec 30, 1991, with 20 new uses approved and 0 published complete response letters.
First approved : Dec 30, 1991 Applications : 39 New uses approved : 20 Complete response letters : 0 Medicare spending, 2025 : $176M
Medicare Spending CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name Product Part Spending, 2025 Change Beneficiaries Sertraline HCl Part D $163M +10% 3,325,589 Zoloft Part D $13.6M -4% 2,641
What Pharmacies Pay Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change SERTRALINE 150 MG CAPSULE: $1.15 per unit Generic · -78% in a year SERTRALINE 20 MG/ML ORAL CONC: $0.393 per ML Generic · -11% in a year SERTRALINE 200 MG CAPSULE: $1.47 per unit Generic · -71% in a year SERTRALINE HCL 100 MG TABLET: $0.051 per unit Generic · 0% in a year SERTRALINE HCL 25 MG TABLET: $0.028 per unit Generic · -16% in a year SERTRALINE HCL 50 MG TABLET: $0.035 per unit Generic · -3% in a year ZOLOFT 100 MG TABLET: $14.94 per unit Brand · +5% in a year ZOLOFT 25 MG TABLET: $15.17 per unit Brand · +7% in a year ZOLOFT 50 MG TABLET: $14.92 per unit Brand · +5% in a year J Zoloft Drugs with a new additional indication for the treatment of posttraumatic stress disorder. · Pfizer Japan Inc. · Mar 20, 2015 Clinical Trials 48 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all Study Phase Status Posted Biomarkers and Pharmacogenomics for Precision Depression Therapy Depression / Major Depressive Disorder · The Fourth Affiliated Hospital of Zhejiang University School of Medicine Not applicable Not yet recruiting Jul 31, 2026 Estimation of Control Before and After Treatment of a Depressive Episode With Serotonin Reuptake Inhibitors Depression Disorder · Hôpital le Vinatier Not applicable Not yet recruiting Jul 21, 2026 Metformin as Adjunct Therapy in Depression-obesity Comorbidity: Clinical and Genetic Evaluation Depression, Depressive Disorder · Riphah International University Not applicable Recruiting Jun 17, 2026 Sertraline Combined With Multi-Strain Probiotics for Adolescent Depression Major Depressive Disorder (MDD), Probiotic Intervention · First Affiliated Hospital of Chongqing Medical University Phase 2 Recruiting Jun 12, 2026 Allopurinol in Depression Depression · Tanta University Phase 2 / Phase 3 Recruiting May 7, 2026 Efficacy and Safety of Sertraline Combined With Lactobacillus Crispatus in Adolescents With Depression Major Depressive Disorder (MDD), Probiotic Intervention · First Affiliated Hospital of Chongqing Medical University Phase 2 Recruiting Apr 20, 2026 TDM-Guided Treatment With SSRIs in Hospitalized Adults and Children Depression - Major Depressive Disorder, Depressive Episodes · Poznan University of Medical Sciences Phase 4 Recruiting Mar 18, 2026 Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms Generalized Anxiety Disorder · Lishu Gao Not applicable Recruiting Feb 6, 2026
Applications NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history Approved Application Sponsor Supplements Marketing Dec 30, 1991 Zoloft NDA 19839 · New molecular entity 68 Marketed Dec 7, 1999 Zoloft NDA 20990 · New dosage form 42 Marketed Jun 30, 2006 Sertraline Hydrochloride ANDA 75719 4 Discontinued Jun 30, 2006 Sertraline Hydrochloride ANDA 76934 5 Marketed Aug 11, 2006 Sertraline Hydrochloride ANDA 76465 11 Marketed Feb 6, 2007 Sertraline Hydrochloride ANDA 76882 12 Marketed Feb 6, 2007 Sertraline Hydrochloride ANDA 76671 10 Discontinued Feb 6, 2007 Sertraline Hydrochloride ANDA 76881 5 Marketed Feb 6, 2007 Sertraline Hydrochloride ANDA 77299 4 Discontinued Feb 6, 2007 Sertraline Hydrochloride ANDA 77345 6 Discontinued Feb 6, 2007 Sertraline Hydrochloride ANDA 77397 10 Marketed Feb 6, 2007 Sertraline Hydrochloride ANDA 77663 7 Discontinued Feb 6, 2007 Sertraline Hydrochloride ANDA 77765 10 Discontinued Feb 6, 2007 Sertraline Hydrochloride ANDA 77818 1 Discontinued Feb 6, 2007 Sertraline Hydrochloride ANDA 78108 0 Discontinued Feb 6, 2007 Sertraline Hydrochloride ANDA 77206 18 Marketed Feb 6, 2007 Sertraline Hydrochloride ANDA 77106 7 Discontinued Feb 6, 2007 Sertraline Hydrochloride ANDA 77162 8 Discontinued Feb 6, 2007 Sertraline Hydrochloride ANDA 77670 15 Marketed Feb 6, 2007 Sertraline Hydrochloride ANDA 77713 5 Marketed Feb 6, 2007 Sertraline Hydrochloride ANDA 77977 15 Discontinued Apr 30, 2007 Sertraline Hydrochloride ANDA 76442 1 Marketed Jan 8, 2008 Sertraline Hydrochloride ANDA 78403 6 Marketed Jan 31, 2008 Sertraline Hydrochloride ANDA 78626 10 Discontinued Oct 31, 2008 Sertraline Hydrochloride ANDA 78861 9 Marketed Mar 4, 2009 Sertraline Hydrochloride ANDA 78677 0 Marketed Aug 10, 2009 Sertraline Hydrochloride ANDA 77864 5 Discontinued Jul 21, 2010 Sertraline Hydrochloride ANDA 78175 0 Marketed Nov 7, 2014 Sertraline Hydrochloride ANDA 202825 5 Marketed May 3, 2021 Sertraline Hydrochloride ANDA 214790 3 Marketed Oct 4, 2021 Sertraline Hydrochloride NDA 215133 · New dosage form 2 Marketed Jul 16, 2025 Sertraline Hydrochloride ANDA 218853 0 Marketed Jan 20, 2026 Sertraline Hydrochloride ANDA 218342 0 Marketed Jan 20, 2026 Sertraline Hydrochloride ANDA 218712 0 Marketed Jan 20, 2026 Sertraline Hydrochloride ANDA 219714 0 Marketed Jan 28, 2026 Sertraline Hydrochloride ANDA 219655 0 Marketed Jan 29, 2026 Sertraline Hydrochloride ANDA 220275 0 Marketed — Sertraline Hydrochloride ANDA 78053 0 Discontinued — Sertraline Hydrochloride ANDA 76540 0 Discontinued
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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