Application 219776
- Type
- NDA
- Sponsor
- BIOCRYST
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | PELLETS;ORAL | EQ 72MG BASE/PACKET | Yes | No |
| 002 | ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | PELLETS;ORAL | EQ 96MG BASE/PACKET | Yes | No |
| 003 | ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | PELLETS;ORAL | EQ 108MG BASE/PACKET | Yes | No |
| 004 | ORLADEYO | BEROTRALSTAT DIHYDROCHLORIDE | PELLETS;ORAL | EQ 132MG BASE/PACKET | Yes | Yes |