approval · primary record
OMEPRAZOLE
3 approval events · latest 2026-03-11
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-03-11 |
| Approval events | 3 |
| Brand | OMEPRAZOLE |
| Sponsor | DEXCEL |
| Route | ORAL |
Approval history
3 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-03-11 | FDA | NDA | OMEPRAZOLE | DEXCEL | ORAL |
| 2025-11-25 | FDA | NDA | ZEGERID OTC | RILEY CONSUMER | ORAL |
| 2025-10-03 | FDA | NDA | OMEPRAZOLE | DEXCEL PHARMA | ORAL |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:28:04.644Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:omeprazole
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Omeprazole · compound