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Data updated: Mar 10, 2026

PROPRANOLOL HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE
Oncology Approved 1967-11-13
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
42
Indications
--
Phase 3 Trials
1
Priority Reviews
58
Years on Market

Details

Status
Prescription
First Approved
1967-11-13
Routes
ORAL, INJECTION
Dosage Forms
TABLET, CAPSULE, EXTENDED RELEASE, SOLUTION, INJECTABLE

Companies

IPCA LABS LTD AMTA Merck Teva INNOGENIX WATSON LABS WARNER CHILCOTT ROXANE WATSON LABS TEVA CHARTWELL RX DURAMED PHARMS BARR SUPERPHARM IVAX SUB TEVA PHARMS INWOOD LABS DAVA PHARMS INC Viatris INTERPHARM Novartis PAI HOLDINGS PHARM LEDERLE ANDA REPOSITORY Lupin PH HEALTH PUREPAC PHARM Hikma MANKIND PHARMA ANI PHARMS UPSHER SMITH LABS IMPAX LABS INC FOSUN PHARMA EXTROVIS SMITH AND NEPHEW VINTAGE PHARMS CHARTWELL INJECTABLE Fresenius Kabi ADARE PHARMS INC Baxter ZYDUS PHARMS USA INC SOLOPAK AIPING PHARM INC NORTHSTAR HLTHCARE
Active Ingredient: PROPRANOLOL HYDROCHLORIDE

PROPRANOLOL HYDROCHLORIDE Approval History

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What PROPRANOLOL HYDROCHLORIDE Treats

6 indications

PROPRANOLOL HYDROCHLORIDE is approved for 6 conditions since its original approval in 1967. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Angina Pectoris
  • Atrial Fibrillation
  • Myocardial Infarction
  • Migraine
  • Essential Tremor
Source: FDA Label

Drugs Similar to PROPRANOLOL HYDROCHLORIDE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

INDERAL LA
PROPRANOLOL HYDROCHLORIDE
3 shared
ANI PHARMS
Shared indications:
HypertensionAngina PectorisMigraine
TIMOLOL MALEATE
TIMOLOL MALEATE
3 shared
RISING
Shared indications:
HypertensionMyocardial InfarctionMigraine
ALISKIREN HEMIFUMARATE
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Shared indications:
HypertensionMyocardial Infarction
ATENOLOL
ATENOLOL
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AIPING PHARM INC
Shared indications:
HypertensionMyocardial Infarction
ATENOLOL AND CHLORTHALIDONE
ATENOLOL
2 shared
WATSON LABS
Shared indications:
HypertensionMyocardial Infarction
AZILSARTAN MEDOXOMIL AND CHLORTHALIDONE
AZILSARTAN KAMEDOXOMIL
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ALKEM LABS LTD
Shared indications:
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AMLODIPINE BESYLATE
2 shared
COSETTE
Shared indications:
HypertensionMyocardial Infarction
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
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2 shared
Baxter
Shared indications:
Atrial FibrillationHypertension
BREVIBLOC IN PLASTIC CONTAINER
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2 shared
Baxter
Shared indications:
Atrial FibrillationHypertension
BYSTOLIC
NEBIVOLOL HYDROCHLORIDE
2 shared
AbbVie
Shared indications:
HypertensionMyocardial Infarction
CADUET
AMLODIPINE BESYLATE
2 shared
PHARMACIA
Shared indications:
HypertensionMyocardial Infarction
CARVEDILOL PHOSPHATE
CARVEDILOL PHOSPHATE
2 shared
Sun Pharma
Shared indications:
Myocardial InfarctionHypertension
COREG
CARVEDILOL
2 shared
WAYLIS THERAP
Shared indications:
Myocardial InfarctionHypertension
COREG CR
CARVEDILOL PHOSPHATE
2 shared
WAYLIS THERAP
Shared indications:
Myocardial InfarctionHypertension
DIOVAN
VALSARTAN
2 shared
Novartis
Shared indications:
HypertensionMyocardial Infarction
DIOVAN HCT
HYDROCHLOROTHIAZIDE
2 shared
Novartis
Shared indications:
HypertensionMyocardial Infarction
EDARBYCLOR
AZILSARTAN KAMEDOXOMIL
2 shared
AZURITY
Shared indications:
HypertensionMyocardial Infarction
ESMOLOL HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE
2 shared
AMNEAL
Shared indications:
Atrial FibrillationHypertension
ESMOLOL HYDROCHLORIDE DOUBLE STRENGTH IN PLASTIC CONTAINER
ESMOLOL HYDROCHLORIDE
2 shared
HQ SPCLT PHARMA
Shared indications:
Atrial FibrillationHypertension
ESMOLOL HYDROCHLORIDE IN PLASTIC CONTAINER
ESMOLOL HYDROCHLORIDE
2 shared
HQ SPCLT PHARMA
Shared indications:
Atrial FibrillationHypertension
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov β†— Pro

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.

PROPRANOLOL HYDROCHLORIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Hypertension Propranolol hydrochloride tablets are indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Propranolol hydrochloride is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Propranolol hydrochloride tablets are indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Atrial Fibrillation Propranolol hydrochloride tablets are indicated to control ventricular rate in patients w...

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Data Sources

FDA Approval: ANDA078955 β†’ Label: DailyMed β†’ Patents: FDA Orange Book β†’ Trials: ClinicalTrials.gov β†’

Data sourced from official FDA and NIH databases. Click links to verify on original sources.