← FDA Drug Approvals (Drugs@FDA)
ORFADIN
NDA · New Drug Application · Sponsor: SWEDISH ORPHAN · Approved 2002-01-18
Drug application
- FDA Application #
NDA021232- Application type
- New Drug Application
- Brand name
- ORFADIN
- Generic name
- NITISINONE
- Active ingredients
- NITISINONE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- SWEDISH ORPHAN
- Manufacturer
- SWEDISH ORPHAN BIOVITRUM AB (PUBL)
- First approval
- 2002-01-18
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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