| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 219616 | NDA | VERASTEM INC | 001 | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | CAPSULE, TABLET;ORAL | EQ 0.8MG BASE;EQ 200MG BASE | AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE | 2025-05-08 | Prescription | Yes |