| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 219070 | NDA | CRINETICS PHARMA INC | 001 | PALSONIFY | TABLET;ORAL | 20MG | PALTUSOTINE | 2025-09-25 | Prescription | No | |
| 002 | PALSONIFY | TABLET;ORAL | 30MG | PALTUSOTINE | 2025-09-25 | Prescription | No |