| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 216196 | NDA | AGIOS PHARMS INC | 001 | PYRUKYND | TABLET;ORAL | EQ 5MG BASE | MITAPIVAT SULFATE | 2022-02-17 | Prescription | No | |
| 002 | PYRUKYND | TABLET;ORAL | EQ 20MG BASE | MITAPIVAT SULFATE | 2022-02-17 | Prescription | No | ||||
| 003 | PYRUKYND | TABLET;ORAL | EQ 50MG BASE | MITAPIVAT SULFATE | 2022-02-17 | Prescription | Yes |