| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 214094 | NDA | BIOCRYST | 001 | ORLADEYO | CAPSULE;ORAL | EQ 110MG BASE | BEROTRALSTAT HYDROCHLORIDE | 2020-12-03 | Prescription | No | |
| 002 | ORLADEYO | CAPSULE;ORAL | EQ 150MG BASE | BEROTRALSTAT HYDROCHLORIDE | 2020-12-03 | Prescription | Yes | ||||
| 206426 | NDA | BIOCRYST | 001 | RAPIVAB | SOLUTION;INTRAVENOUS | 200MG/20ML (10MG/ML) | PERAMIVIR | 2014-12-19 | Prescription | Yes |