# OMEPRAZOLE
> **ANDA075785** · Abbreviated New Drug Application (Generic) · Sponsor: IMPAX LABS · Approved 2007-10-22
## Drug
- **FDA Application Number:** ANDA075785
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** OMEPRAZOLE
- **Generic name:** Omeprazole
- **Active ingredients:** OMEPRAZOLE
- **Dosage form:** CAPSULE, DELAYED REL PELLETS
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** IMPAX LABS
- **First approval:** 2007-10-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=075785)
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