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Data updated: Mar 10, 2026

INDERAL LA

PROPRANOLOL HYDROCHLORIDE
Cardiovascular Approved 1983-04-19
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
4
Indications
--
Phase 3 Trials
42
Years on Market

Details

Status
Prescription
First Approved
1983-04-19
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

ANI PHARMS
Active Ingredient: PROPRANOLOL HYDROCHLORIDE

INDERAL LA Approval History

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What INDERAL LA Treats

4 indications

INDERAL LA is approved for 4 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypertension
  • Angina Pectoris
  • Migraine
  • Hypertrophic Subaortic Stenosis
Source: FDA Label

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Trial Timeline

ClinicalTrials.gov โ†— 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.

INDERAL LA FDA Label Details

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Indications & Usage

FDA Label (PDF)

Hypertension Inderal LA is indicated in the management of hypertension. It may be used alone or used in combination with other antihypertensive agents, particularly a thiazide diuretic. Inderal LA is not indicated in the management of hypertensive emergencies. Angina Pectoris Due to Coronary Atherosclerosis Inderal LA is indicated to decrease angina frequency and increase exercise tolerance in patients with angina pectoris. Migraine Inderal LA is indicated for the prophylaxis of common migraine headache. The efficacy of propranolol in the treatment of a migraine attack that has started has not...

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Data Sources

FDA Approval: NDA018553 โ†’ Label: DailyMed โ†’ Patents: FDA Orange Book โ†’ Trials: ClinicalTrials.gov โ†’

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