TheraRadar
Data updated: Jun 28, 2026

ZANTAC 75 (ranitidine hydrochloride) · CHATTEM SANOFI

Trial Activity: Declining
Gastrointestinal Approved 1995-12-19

ZANTAC 75 is FDA-approved to treat 7 conditions (same as RANITIDINE HYDROCHLORIDE).

Source: FDA Label
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)
4
Indications
--
Phase 3 Trials
30
Years on Market

Details

Status
Discontinued
First Approved
1995-12-19
Routes
ORAL
Dosage Forms
TABLET, EFFERVESCENT, TABLET

Companies

CHATTEM SANOFI
Active Ingredient: RANITIDINE HYDROCHLORIDE

ZANTAC 75 Approval History

1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
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2018
2019
2020
2021
2022
2023
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2025
2026
Original
New Indication
New Form
Label Update
23 FDA actions from 1995 to 2019 · 2 indication expansions
Sep 2019 SUPPL
Label · Labeling
FDA Letter Label
Apr 2019 SUPPL
Label · Labeling
FDA Letter Label
Jul 2016 SUPPL
Label · Labeling
FDA Letter Label

What ZANTAC 75 Treats

7 indications

ZANTAC 75 is approved for 7 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as RANITIDINE HYDROCHLORIDE (same active ingredient).

Source: FDA Label
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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

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Ongoing clinical trials by development phase

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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 ↗ 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 75 FDA Label Details

Indications & Usage

FDA Label (PDF)

ZANTAC 75 is FDA-approved to treat 7 conditions — same approved indications as RANITIDINE HYDROCHLORIDE.

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Data Sources

FDA Approval: NDA020745 → 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