# ORLADEYO
> **NDA214094** · New Drug Application · Sponsor: BIOCRYST · Approved 2020-12-03
## Drug
- **FDA Application Number:** NDA214094
- **Application type:** New Drug Application
- **Brand name:** ORLADEYO
- **Generic name:** BEROTRALSTAT HYDROCHLORIDE
- **Active ingredients:** BEROTRALSTAT DIHYDROCHLORIDE
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** BIOCRYST
- **Manufacturer:** BioCryst Pharmaceuticals, Inc.
- **First approval:** 2020-12-03
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214094)
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