OMEPRAZOLE
Details
- Status
- Prescription
- First Approved
- 2002-07-31
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED REL PELLETS, TABLET, DELAYED RELEASE, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Companies
OMEPRAZOLE Approval History
What OMEPRAZOLE Treats
1 indicationsOMEPRAZOLE is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Heartburn
Drugs Similar to OMEPRAZOLE
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
OMEPRAZOLE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Use(s) treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect
OMEPRAZOLE Patents & Exclusivity
Patents (2 active)
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.