NITISINONE Pharmacologic Class Indexing
- Class set ID
- 94aeebc5-0cfd-4df4-810a-afd1b547efc4
- Version
- 4
- Effective date
- 20211129
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use NITYR safely and effectively. See full prescribing information for NITYR. NITYR ® (nitisinone) tablets, for oral use Initial U.S. Approval: 2002 | Cycle Pharmaceuticals Ltd. | Rivopharm SA | Penn Pharmaceutical Services Limited | Catalent Nottingham Limited | Pharmaron Manufacturing Services (UK) Limited | Central Pharma Contract Packing Limited | 20251222 | 13 |
| These highlights do not include all the information needed to use ORFADIN safely and effectively. See full prescribing information for ORFADIN. ORFADIN ® (nitisinone) capsules, for oral use ORFADIN ® (nitisinone) oral suspension Initial U.S. Approval: 2002 | Swedish Orphan Biovitrum AB (publ) | 20251218 | 12 |
| These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use Initial U.S. Approval: 2002 | Analog Pharma | 20250905 | 7 |
| These highlights do not include all the information needed to use HARLIKU safely and effectively. See full prescribing information for HARLIKU. HARLIKU TM (nitisinone) tablets, for oral use Initial U.S. Approval: 2002 | Cycle Pharmaceuticals Ltd. | Rivopharm SA | Penn Pharmaceutical Services Limited | Catalent Nottingham Limited | Pharmaron Manufacturing Services (UK) Limited | Central Pharma Contract Packing Limited | 20250602 | 1 |
| These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use Initial U.S. Approval: 2002 | Endo USA, Inc. | 20250331 | 7 |
| HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE Capsules, for oral use Initial U.S. Approval: 2002 | Eton Pharmaceuticals, Inc. | 20240202 | 5 |
| These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use. Initial U.S. Approval: 2002 | Bryant Ranch Prepack | 20240110 | 102 |
| These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use. Initial U.S. Approval: 2002 | Bryant Ranch Prepack | 20240110 | 104 |
| These highlights do not include all the information needed to use NITISINONE CAPSULES safely and effectively. See full prescribing information for NITISINONE CAPSULES. NITISINONE capsules, for oral use. Initial U.S. Approval: 2002 | Bryant Ranch Prepack | 20240110 | 102 |
| These highlights do not include all the information needed to use ORFADIN safely and effectively. See full prescribing information for ORFADIN. ORFADIN ® (nitisinone) capsules, for oral use ORFADIN ® (nitisinone) oral suspension Initial U.S. Approval: 2002 | SWEDISH ORPHAN BIOVITRUM AB (PUBL) | Apotek Produktion & Laboratorier AB | 20211130 | 14 |