# FABHALTA
> **NDA218276** · New Drug Application · Sponsor: NOVARTIS · Approved 2023-12-05
## Drug
- **FDA Application Number:** NDA218276
- **Application type:** New Drug Application
- **Brand name:** FABHALTA
- **Generic name:** IPTACOPAN
- **Active ingredients:** IPTACOPAN HYDROCHLORIDE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** NOVARTIS
- **Manufacturer:** Novartis Pharmaceuticals Corporation
- **First approval:** 2023-12-05
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218276)
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