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Data updated: Mar 10, 2026

RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE
Cardiovascular Approved 1997-07-31
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
67
Indications
--
Phase 3 Trials
28
Years on Market

Details

Status
Prescription
First Approved
1997-07-31
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE, SYRUP, CAPSULE

Companies

Dr. Reddy's Hikma WOCKHARDT ZYDUS PHARMS USA INC Apotex STRIDES PHARMA Novartis PH HEALTH Viatris BEDFORD Sun Pharma ANI PHARMS PHARMOBEDIENT SUN PHARMA CANADA RANBAXY EPIC PHARMA LLC PERRIGO R AND D THINQ PHARM-CRO PVT Teva VKT PHARMA APPCO WATSON LABS WOCKHARDT LTD PHARM ASSOC AMNEAL PHARMS LANNETT CO INC NOSTRUM LABS INC NOVITIUM PHARMA Aurobindo Pharma CONTRACT PHARMACAL PERRIGO AJANTA PHARMA LTD HERITAGE PHARMA AVET GLENMARK PHARMS INC AMNEAL PHARMS NY TOLMAR TORRENT GRANULES MPP PHARMA Boehringer Ingelheim
Active Ingredient: RANITIDINE HYDROCHLORIDE

RANITIDINE HYDROCHLORIDE Approval History

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What RANITIDINE HYDROCHLORIDE Treats

7 indications

RANITIDINE HYDROCHLORIDE is approved for 7 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Duodenal Ulcer
  • Pathological Hypersecretory Conditions
  • Zollinger-Ellison Syndrome
  • Systemic Mastocytosis
  • Gastric Ulcer
  • Gastroesophageal Reflux Disease
  • Erosive Esophagitis
Source: FDA Label

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Erosive EsophagitisGastroesophageal Reflux DiseaseGastric Ulcer +3 more
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SHORLA ONCOLOGY
Shared indications:
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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.

RANITIDINE HYDROCHLORIDE FDA Label Details

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Indications & Usage

Ranitidine is indicated in: 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year. 3.The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis). 4. Short-term treatment of active...

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Data Sources

FDA Approval: ANDA076705 → Label: DailyMed → Trials: ClinicalTrials.gov →

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