| 0254-3020 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Par Pharmaceutical, Inc. | ACTIVE |
| 0254-3021 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Par Pharmaceutical, Inc. | ACTIVE |
| 0254-3022 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Par Pharmaceutical, Inc. | ACTIVE |
| 13668-629 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Torrent Pharmaceuticals Limited | ACTIVE |
| 13668-630 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Torrent Pharmaceuticals Limited | ACTIVE |
| 13668-631 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Torrent Pharmaceuticals Limited | ACTIVE |
| 13668-632 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Torrent Pharmaceuticals Limited | ACTIVE |
| 63629-2233 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Bryant Ranch Prepack | ACTIVE |
| 63629-2234 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Bryant Ranch Prepack | ACTIVE |
| 63629-2235 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Bryant Ranch Prepack | ACTIVE |
| 66658-102 | Orfadin | Non-Proprietary Name: Nitisinone | Capsule | Oral | Swedish Orphan Biovitrum Ab (publ) | ACTIVE |
| 66658-105 | Orfadin | Non-Proprietary Name: Nitisinone | Capsule | Oral | Swedish Orphan Biovitrum Ab (publ) | ACTIVE |
| 66658-110 | Orfadin | Non-Proprietary Name: Nitisinone | Capsule | Oral | Swedish Orphan Biovitrum Ab (publ) | ACTIVE |
| 66658-120 | Orfadin | Non-Proprietary Name: Nitisinone | Capsule | Oral | Swedish Orphan Biovitrum Ab (publ) | ACTIVE |
| 66658-204 | Orfadin | Non-Proprietary Name: Nitisinone | Suspension | Oral | Swedish Orphan Biovitrum Ab (publ) | ACTIVE |
| 70505-202 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Analog Pharma | ACTIVE |
| 70505-205 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Analog Pharma | ACTIVE |
| 70505-210 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Analog Pharma | ACTIVE |
| 70505-220 | Nitisinone | Non-Proprietary Name: Nitisinone | Capsule | Oral | Analog Pharma | ACTIVE |
| 70709-000 | Nityr | Non-Proprietary Name: Nitisinone | Tablet | Oral | Cycle Pharmaceuticals Ltd. | ACTIVE |
| 70709-002 | Nityr | Non-Proprietary Name: Nitisinone | Tablet | Oral | Cycle Pharmaceuticals Ltd. | ACTIVE |
| 70709-005 | Nityr | Non-Proprietary Name: Nitisinone | Tablet | Oral | Cycle Pharmaceuticals Ltd. | ACTIVE |