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Last Updated: November 22, 2024

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. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Summary for 021232
Tradename:ORFADIN
Applicant:Swedish Orphan
Ingredient:nitisinone
Patents:0
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MG
Approval Date:Jan 18, 2002TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength5MG
Approval Date:Jan 18, 2002TE:ABRLD:Yes

Profile for product number 003

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

Expired US Patents for NDA 021232

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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