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Details for New Drug Application (NDA): 021232

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NDA 021232 describes ORFADIN, which is a drug marketed by Swedish Orphan and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ORFADIN profile page.

The generic ingredient in ORFADIN is nitisinone. One supplier is listed for this compound. Additional details are available on the nitisinone profile page.

Summary for NDA: 021232

Tradename:
ORFADIN
Applicant:
Swedish Orphan
Ingredient:
nitisinone
Patents:0
Therapeutic Class:Enzyme Replacements/Modifiers

Pharmacology for NDA: 021232

Suppliers and Packaging for NDA: 021232

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ORFADIN
nitisinone
CAPSULE;ORAL 021232 NDA SWEDISH ORPHAN BIOVITRUM AB (PUBL) 66658-102 66658-102-60 1 BOTTLE, PLASTIC in 1 CARTON (66658-102-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC
ORFADIN
nitisinone
CAPSULE;ORAL 021232 NDA SWEDISH ORPHAN BIOVITRUM AB (PUBL) 66658-105 66658-105-60 1 BOTTLE, PLASTIC in 1 CARTON (66658-105-60) > 60 CAPSULE in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MG
Approval Date:Jan 18, 2002TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jan 18, 2002TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jan 18, 2002TE:RLD:Yes

Expired Orange Book Patents for NDA: 021232

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-001Jan 18, 20025,006,158► subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-003Jan 18, 20025,006,158► subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-002Jan 18, 20025,550,165► subscribe
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