Application 206356
- Type
- NDA
- Sponsor
- SWEDISH ORPHAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORFADIN | NITISINONE | SUSPENSION;ORAL | 4MG/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66658-204 | ORFADIN | nitisinone | Swedish Orphan Biovitrum AB (publ) | NDA | Current |
| 66658-204 | ORFADIN | nitisinone | Swedish Orphan Biovitrum AB (publ) | NDA | Current |
| 66658-204 | ORFADIN | nitisinone | Swedish Orphan Biovitrum AB (publ) | NDA | Current |
| 66658-204 | ORFADIN | nitisinone | Swedish Orphan Biovitrum AB (publ) | NDA | Current |