| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 213687 | NDA | ULTRAGENYX PHARM INC | 001 | DOJOLVI | LIQUID;ORAL | 100% w/w | TRIHEPTANOIN | 2020-06-30 | Prescription | Yes | |
| 761047 | BLA | ULTRAGENYX PHARM INC | 001 | MEPSEVII | INJECTABLE;INJECTION | 10MG/5ML | VESTRONIDASE ALFA-VJBK | 2017-11-15 | Prescription | No |