| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 219407 | NDA | IONIS PHARMS INC | 001 | DAWNZERA (AUTOINJECTOR) | SOLUTION;SUBCUTANEOUS | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | DONIDALORSEN SODIUM | 2025-08-21 | Prescription | Yes | |
| 218614 | NDA | IONIS PHARMS INC | 001 | TRYNGOLZA (AUTOINJECTOR) | SOLUTION;SUBCUTANEOUS | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | OLEZARSEN SODIUM | 2024-12-19 | Prescription | Yes |