# OMEPRAZOLE AND SODIUM BICARBONATE
> **ANDA204228** · Abbreviated New Drug Application (Generic) · Sponsor: AJANTA PHARMA LTD · Approved 2016-07-15
## Drug
- **FDA Application Number:** ANDA204228
- **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:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** AJANTA PHARMA LTD
- **Manufacturer:** Ajanta Pharma USA Inc.
- **First approval:** 2016-07-15
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204228)
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