Data updated: Mar 10, 2026
ZANTAC 300
RANITIDINE HYDROCHLORIDE
Approved 1983-06-09
10
Indications
--
Phase 3 Trials
42
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1983-06-09
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
ZANTAC 300 Approval History
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What ZANTAC 300 Treats
10 FDA approvalsOriginally approved for its first indication in 1983 . Covers 10 distinct patient populations.
- Other (10)
Other
(10 approvals)- • Approved indication (Jun 1983)
- • Approved indication (Jun 1985)
- • Approved indication (Dec 1985)
- • Approved indication (May 1986)
- • Approved indication (May 1992)
- • Approved indication (Feb 1994)
- • Approved indication (Mar 1994)
- • Approved indication (Nov 1994)
- • Approved indication (Mar 1995)
- • Approved indication (Oct 1999)Letter
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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
Data sourced from official FDA and NIH databases. Click links to verify on original sources.