# TALICIA
> **NDA213004** · New Drug Application · Sponsor: TALICIA HOLDINGS · Approved 2019-11-01
## Drug
- **FDA Application Number:** NDA213004
- **Application type:** New Drug Application
- **Brand name:** TALICIA
- **Generic name:** OMEPRAZOLE MAGNESIUM, AMOXICILLIN AND RIFABUTIN
- **Active ingredients:** AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN
- **Dosage form:** CAPSULE, DELAYED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** TALICIA HOLDINGS
- **Manufacturer:** RedHill Biopharma Ltd
- **First approval:** 2019-11-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213004)
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