ZANTAC IN PLASTIC CONTAINER (ranitidine hydrochloride) · PAI HOLDINGS PHARM
ZANTAC IN PLASTIC CONTAINER is FDA-approved to treat 7 conditions (same as RANITIDINE HYDROCHLORIDE).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1986-12-17
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ZANTAC IN PLASTIC CONTAINER Approval History
What ZANTAC IN PLASTIC CONTAINER Treats
7 indicationsZANTAC IN PLASTIC CONTAINER is approved for 7 conditions since its original approval in 1986. 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
Same approved indications as RANITIDINE HYDROCHLORIDE (same active ingredient).
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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
FDA Label (PDF)ZANTAC IN PLASTIC CONTAINER is FDA-approved to treat 7 conditions — same approved indications as RANITIDINE HYDROCHLORIDE.
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Data Sources
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