Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021232

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ORFADIN (NITISINONE)
2MG
Marketing Status: Prescription

Active Ingredient: NITISINONE
Proprietary Name: ORFADIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021232
Product Number: 001
Approval Date: Jan 18, 2002
Applicant Holder Full Name: SWEDISH ORPHAN BIOVITRUM AB PUBL
Marketing Status:  Prescription
Patent and Exclusivity Information

ORFADIN (NITISINONE)
5MG
Marketing Status: Prescription

Active Ingredient: NITISINONE
Proprietary Name: ORFADIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021232
Product Number: 002
Approval Date: Jan 18, 2002
Applicant Holder Full Name: SWEDISH ORPHAN BIOVITRUM AB PUBL
Marketing Status:  Prescription
Patent and Exclusivity Information

ORFADIN (NITISINONE)
10MG
Marketing Status: Prescription

Active Ingredient: NITISINONE
Proprietary Name: ORFADIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021232
Product Number: 003
Approval Date: Jan 18, 2002
Applicant Holder Full Name: SWEDISH ORPHAN BIOVITRUM AB PUBL
Marketing Status:  Prescription
Patent and Exclusivity Information

ORFADIN (NITISINONE)
20MG
Marketing Status: Prescription

Active Ingredient: NITISINONE
Proprietary Name: ORFADIN
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021232
Product Number: 004
Approval Date: Jun 13, 2016
Applicant Holder Full Name: SWEDISH ORPHAN BIOVITRUM AB PUBL
Marketing Status:  Prescription
Patent and Exclusivity Information