# PRILOSEC OTC
> **NDA021229** · New Drug Application · Sponsor: ASTRAZENECA · Approved 2003-06-20
## Drug
- **FDA Application Number:** NDA021229
- **Application type:** New Drug Application
- **Brand name:** PRILOSEC OTC
- **Generic name:** OMEPRAZOLE MAGNESIUM
- **Active ingredients:** OMEPRAZOLE MAGNESIUM
- **Dosage form:** TABLET, DELAYED RELEASE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** ASTRAZENECA
- **Manufacturer:** The Procter & Gamble Manufacturing Company
- **First approval:** 2003-06-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021229)
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