TheraRadar
Data updated: May 26, 2026

ZANTAC 300 (ranitidine hydrochloride)

Trial Activity: Declining
Gastrointestinal Approved 1983-06-09
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Sanofi conducting 3 trials (16%)
59 indications explored (Broad Platform)
→ healthy (2 trials)
→ gastroesophageal reflux disease (gerd) (2 trials)
→ pharmacokinetics (2 trials)
10
Indications
--
Phase 3 Trials
42
Years on Market

Details

Status
Discontinued
First Approved
1983-06-09
Routes
ORAL
Dosage Forms
TABLET, CAPSULE

Companies

GSK
Active Ingredient: RANITIDINE HYDROCHLORIDE

ZANTAC 300 Approval History

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Original
New Indication
New Form
Label Update
76 FDA actions from 1983 to 2009 · 6 indication expansions
Sep 2009 SUPPL
Label · Labeling
FDA Letter Label
Feb 2009 SUPPL
Label · Labeling
FDA Letter Label
Jul 2006 SUPPL
Label · Labeling
FDA Letter

What ZANTAC 300 Treats

10 FDA approvals

Originally approved for its first indication in 1983 . Covers 10 distinct patient populations.

  • Other (10)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02195804 1144.3 Ph 1 completed Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) in Fasting, Healthy Male Volunteers
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ 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.

ZANTAC 300 FDA Label Details

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Data Sources

FDA Approval: NDA018703 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment