Application 213687
- Type
- NDA
- Sponsor
- ULTRAGENYX PHARM INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DOJOLVI | TRIHEPTANOIN | LIQUID;ORAL | 35% | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 69794-050 | DOJOLVI | Triheptanoin | Ultragenyx Pharmaceutical Inc. | NDA | Current |
| 69794-050 | DOJOLVI | Triheptanoin | Ultragenyx Pharmaceutical Inc. | NDA | Current |
| 69794-050 | DOJOLVI | Triheptanoin | Ultragenyx Pharmaceutical Inc. | NDA | Current |
| 69794-050 | DOJOLVI | Triheptanoin | Ultragenyx Pharmaceutical Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76008 | SUPPL | 2023-10-31 |
| 75989 | SUPPL | 2023-10-31 |
| 64123 | ORIG | 2020-07-29 |
| 63772 | ORIG | 2020-07-01 |
| 63761 | ORIG | 2020-06-30 |