← FDA Drug Approvals (Drugs@FDA)
TALICIA
NDA · New Drug Application · Sponsor: TALICIA HOLDINGS · Approved 2019-11-01
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown