Active ingredient
Nitisinone
23 finished FDA listings contain Nitisinone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NITISINONE
- Dosage forms
- Capsule, Suspension, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 10 mg/1 · 2 mg/1 · 20 mg/1 · 4 mg/ml · 5 mg/1
- Brand names in FDA listings
- Harliku, Nityr, Orfadin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 61805
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 021232 | SWEDISH ORPHAN | 2002-01-18 | 4 |
| NDA 206356 | SWEDISH ORPHAN | 2016-04-22 | 1 |
| NDA 209449 | CYCLE | 2017-07-26 | 4 |
| ANDA 211041 | NOVITIUM PHARMA | 2019-08-26 | 6 |
| ANDA 212390 | MEDUNIK | 2022-05-26 | 4 |
| ANDA 216201 | ETON | 2023-05-25 | 4 |
Official labeling on DailyMed
- NITISINONE CAPSULE [PAR HEALTH USA, LLC] · version 8 · 2026-08-07
- NITYR (NITISINONE) TABLET [CYCLE PHARMACEUTICALS LTD.] · version 13 · 2025-12-23
- ORFADIN (NITISINONE) SUSPENSION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] · version 12 · 2025-12-22
- NITISINONE CAPSULE [ETON PHARMACEUTICALS, INC.] · version 5 · 2025-11-17
- NITISINONE CAPSULE [ANALOG PHARMA] · version 7 · 2025-09-15
- HARLIKU (NITISINONE) TABLET [CYCLE PHARMACEUTICALS LTD.] · version 1 · 2025-07-22
- NITISINONE CAPSULE [BRYANT RANCH PREPACK] · version 102 · 2024-01-12
- NITISINONE CAPSULE [BRYANT RANCH PREPACK] · version 104 · 2024-01-12
- NITISINONE CAPSULE [BRYANT RANCH PREPACK] · version 102 · 2024-01-11
- ORFADIN (NITISINONE) CAPSULE [SWEDISH ORPHAN BIOVITRUM AB (PUBL)] · version 14 · 2022-06-14
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.