# OMEPRAZOLE
> **NDA209400** · New Drug Application · Sponsor: DEXCEL · Approved 2017-07-05
## Drug
- **FDA Application Number:** NDA209400
- **Application type:** New Drug Application
- **Brand name:** OMEPRAZOLE
- **Generic name:** OMEPRAZOLE
- **Active ingredients:** OMEPRAZOLE
- **Dosage form:** TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** DEXCEL
- **Manufacturer:** BJWC
- **First approval:** 2017-07-05
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209400)
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