Home Applications 021232 Application 021232
Type NDA
Sponsor SWEDISH ORPHAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ORFADIN NITISINONE CAPSULE;ORAL 2MG Yes No 002 ORFADIN NITISINONE CAPSULE;ORAL 5MG Yes No 003 ORFADIN NITISINONE CAPSULE;ORAL 10MG Yes No 004 ORFADIN NITISINONE CAPSULE;ORAL 20MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021232-001 ORFADIN NITISINONE 2MG CAPSULE / ORAL AB RLD 2002-01-18 N021232-002 ORFADIN NITISINONE 5MG CAPSULE / ORAL AB RLD 2002-01-18 N021232-003 ORFADIN NITISINONE 10MG CAPSULE / ORAL AB RLD 2002-01-18 N021232-004 ORFADIN NITISINONE 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021232-001 ORFADIN 2MG CAPSULE / ORAL AB RLD 2002-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021232-002 ORFADIN 5MG CAPSULE / ORAL AB RLD 2002-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021232-003 ORFADIN 10MG CAPSULE / ORAL AB RLD 2002-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021232-004 ORFADIN 20MG CAPSULE / ORAL AB RLD, RS 2016-06-13 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 148 observed states.
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 66658-102 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-102 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-102 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-105 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-105 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-105 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-110 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-110 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-110 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-120 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-120 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current 66658-120 Orfadin Nitisinone SWEDISH ORPHAN BIOVITRUM AB (PUBL) NDA Current