Data updated: Nov 8, 2026
TENORETIC 100 (atenolol) · TWI PHARMS
Cardiovascular
Approved 1984-06-08
This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →
1
Indication
--
Phase 3 Trials
42
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1984-06-08
- Routes
- ORAL
- Dosage Forms
- TABLET
TENORETIC 100 Approval History
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Original
New Indication
New Form
Label Update
30 FDA actions from 1984 to 2023
Apr 2000 SUPPL
Label
Jul 1999 SUPPL
Label
Oct 1996 SUPPL
Mfg
Feb 1996 SUPPL
Label
May 1994 SUPPL
Label
Jun 1993 SUPPL
Label
Apr 1993 SUPPL
Label
Aug 1992 SUPPL
Label
Sep 1991 SUPPL
Label
Apr 1991 SUPPL
Label
Jan 1987 SUPPL
Mfg
Sep 1985 SUPPL
Mfg
Aug 1985 SUPPL
Mfg
Jun 1985 SUPPL
Mfg
Jan 1985 SUPPL
Mfg
Nov 1984 SUPPL
Mfg
Nov 1984 SUPPL
Mfg
Aug 1984 SUPPL
Label
Aug 1984 SUPPL
Mfg
Jun 1984 ORIGINAL
New Combo
What TENORETIC 100 Treats
1 FDA approvalsOriginally approved for its first indication in 1984 .
- Other (1)
Other
(1 approval)- • Approved indication (Jun 1984)
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Clinical Trial Registry
23 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07268170 HEART-BEAT | 2025-522741-21-00 2025-522741-21-00 | Ph 2, Ph 3 | enrolling by invitation | Heart Rate Control Before Cardiac Computed Tomography in Adults for the Evaluation of Coronary Artery Disease |
| NCT02479204 | AC-064-102 | Ph 1 | terminated | Clinical Study to Investigate Safety and Effects on Heart Rate, Blood Pressure, and Pharmacokinetic Interactions of ACT-334441 |
| NCT02560805 ANG-P | IRB00082400 2025P010213 | Ph 2 | recruiting | Role of Sympathetic Overactivity and Angiotensin II in PTSD and CV |
| NCT03578354 | Pending | Ph 2 | withdrawn | 4-Aminopyridine, Atenolol, or Placebo in Patients With Vestibular Migraine |
| NCT03082014 TREAT-SVDs | TRE-1486--0105-I | Ph 3 | terminated | Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function |
| NCT02342275 results posted | 2014-229 | Ph 3 | completed | Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma |
| NCT01522950 EVIDENCE results posted | CV-2014-20226 | Ph 2 | completed | A Study Examining the Effects of Nebivolol Compared to Atenolol on Endothelial Function |
| NCT00925119 results posted | HP-00040291 K23HL091120 | Ph 4 | terminated | Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes |
| NCT01202721 BAV results posted | BAV-15JUNE2010 | Ph 3 | terminated | Beta Blockers and Angiotensin Receptor Blockers in Bicuspid Aortic Valve Disease Aortopathy (BAV Study) |
| NCT01132768 CONFIRM | DSE-OLM-01-09 | Ph 4 | terminated | The Confirmatory Olmesartan Plaque Regression Study |
| NCT00669279 results posted | 8COG11059 | Ph 4 | completed | Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure |
| NCT01715207 results posted | 2009-10-025 | Ph 3 | completed | Comparison of Aliskiren vs Negative Controls on Aortic Stiffness in Patients With MFS |
| NCT03070730 results posted | 2011P000246 R01HL059459 | Ph 1, Ph 2 | terminated | Hemodynamic Response of Neuropathic And Non-Neuropathic POTS Patients To Adrenoreceptor Agonist And Antagonist |
| NCT01251146 results posted | EMR200006-515 | Ph 4 | completed | A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension |
| NCT01736488 | BR-FA-CT-401 | Ph 4 | completed | Clinical Study to Evaluate the Antihypertensive Efficacy and Changes of Neurohormonal Markers of Fimasartan and Atenolol With Exaggerated Blood Pressure Response During Exercise in Essential Hypertensive Patients |
| NCT02547597 | CARVEDILOL | Ph 4 | completed | Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris |
| NCT01230892 results posted | IRB00027953 Emory #00000681 | Ph 4 | completed | Evaluation of The Effects of Nebivolol in Comparison to Atenolol on Wall Shear Stress and Rupture Prone Coronary Plaques |
| NCT01939509 CHAB | 1445 | Ph 4 | completed | Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol |
| NCT01079962 results posted | EMD 084000-505 | Ph 4 | completed | An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION]) |
| NCT01762436 | Betablocker on CAP and BRS | Ph 4 | completed | Effects of Bisoprolol and Atenolol on Sympathetic Nervous Activity and Central Aortic Pressure in Patients With Essential Hypertension |
| NCT00593710 | H07-01816 | Ph 2 | completed | Losartan Versus Atenolol for the Treatment of Marfan Syndrome |
| NCT01445964 | SNUCPT11_ATE Pan Asian-Atenolol-1 | Ph 4 | completed | Effect of SLCO2B1 Genotype and Apple Juice on Pharmacokinetics of Atenolol After Oral Administration in Healthy Male Korean |
| NCT01022463 IVA-MS | F-2/IEC/MAMC/09/No.192 | Ph 3 | completed | Effect of Ivabradine on Heart Rate & Effort Tolerance in Mitral Stenosis in Sinus Rhythm |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TENORETIC 100 FDA Label Details
This product's label text is not in FDA's label database (openFDA, DailyMed). FDA's label document for this approval (Drugs@FDA PDF) →
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.