NEXIUM 24HR (esomeprazole magnesium) · AstraZeneca
NEXIUM 24HR is FDA-approved to treat 8 conditions (same as ESOMEPRAZOLE MAGNESIUM).
Details
- Status
- Over-the-counter
- First Approved
- 2014-03-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE, TABLET, DELAYED RELEASE
NEXIUM 24HR Approval History
What NEXIUM 24HR Treats
8 indicationsNEXIUM 24HR is approved for 8 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Erosive Esophagitis
- Heartburn
- Gastroesophageal Reflux Disease
- Gastric Ulcer
- Helicobacter Pylori Infection
- Duodenal Ulcer
- Zollinger-Ellison Syndrome
- Pathological Hypersecretory Conditions
Same approved indications as ESOMEPRAZOLE MAGNESIUM (same active ingredient).
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01135472 | 08197 | Ph 1 | completed | Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy 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.
NEXIUM 24HR FDA Label Details
Indications & Usage
FDA Label (PDF)NEXIUM 24HR is FDA-approved to treat 8 conditions — same approved indications as ESOMEPRAZOLE MAGNESIUM.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.