# OMEPRAZOLE AND SODIUM BICARBONATE
> **ANDA219161** · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2025-12-10
## Drug
- **FDA Application Number:** ANDA219161
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** OMEPRAZOLE AND SODIUM BICARBONATE
- **Generic name:** OMEPRAZOLE AND SODIUM BICARBONATE
- **Active ingredients:** OMEPRAZOLE; SODIUM BICARBONATE
- **Dosage form:** FOR SUSPENSION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** NOVITIUM PHARMA
- **Manufacturer:** ANI Pharmaceuticals, Inc.
- **First approval:** 2025-12-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219161)
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