OMEPRAZOLE MAGNESIUM · PERRIGO R AND D
OMEPRAZOLE MAGNESIUM is FDA-approved to treat 6 conditions (same as PRILOSEC).
Details
- Status
- Prescription
- First Approved
- 1989-09-14
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE, CAPSULE, DELAYED RELEASE
Companies
OMEPRAZOLE MAGNESIUM Approval History
What OMEPRAZOLE MAGNESIUM Treats
6 indicationsOMEPRAZOLE MAGNESIUM is approved for 6 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Duodenal Ulcer
- Helicobacter pylori Infection
- Gastric Ulcer
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Pathologic Hypersecretory Conditions
Same approved indications as PRILOSEC (same active ingredient).
Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00674115 results posted | 18133 CL2007-17, P07813 | Ph 3 | completed | A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED) |
| NCT01337804 | 18136 P08050 | Ph 1 | completed | A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12) |
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 MAGNESIUM FDA Label Details
Indications & Usage
OMEPRAZOLE MAGNESIUM is FDA-approved to treat 6 conditions — same approved indications as PRILOSEC.
Looking for the branded version?
PRILOSEC
Full clinical data, patents, trials, and competitive landscape for omeprazole magnesium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.