Home Applications 209449 Application 209449
Type NDA
Sponsor CYCLE PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NITYR NITISINONE TABLET;ORAL 2MG Yes No 002 NITYR NITISINONE TABLET;ORAL 5MG Yes No 003 NITYR NITISINONE TABLET;ORAL 10MG Yes Yes 004 HARLIKU NITISINONE TABLET;ORAL 2MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N209449-001 NITYR NITISINONE 2MG TABLET / ORAL RLD 2017-07-26 N209449-002 NITYR NITISINONE 5MG TABLET / ORAL RLD 2017-07-26 N209449-003 NITYR NITISINONE 10MG TABLET / ORAL RLD, RS 2017-07-26 N209449-004 HARLIKU NITISINONE 2MG TABLET / ORAL RLD, RS 2025-06-10
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209449-004 ODE-529 2032-06-10
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 4 · 127 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 2026-02-19 14:30 UTC 2026-02 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-004 HARLIKU 2MG TABLET / ORAL RLD, RS 2025-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-004 HARLIKU 2MG TABLET / ORAL RLD, RS 2025-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-004 HARLIKU 2MG TABLET / ORAL RLD, RS 2025-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209449-002 NITYR 5MG TABLET / ORAL RLD 2017-07-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209449-003 NITYR 10MG TABLET / ORAL RLD, RS 2017-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209449-001 NITYR 2MG TABLET / ORAL RLD 2017-07-26 1e350fbaab3a…
Observed Orange Book patent history# Patent history page 1 of 3 · 120 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209449-002 10328029 2035-01-05 U-1836 Drug product 2019-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209449-003 10328029 2035-01-05 U-1836 Drug product 2019-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209449-001 10328029 2035-01-05 U-1836 Drug product 2019-07-17 8072bd15b7f6…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209449-004 ODE-529 2032-06-10 a50c72e98297…
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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70709-000 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-000 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-000 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-000 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-000 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-000 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-000 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-002 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-002 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-002 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-002 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-002 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-002 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-002 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-005 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-005 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-005 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-005 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-005 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-005 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current 70709-005 NITYR Nitisinone Cycle Pharmaceuticals Ltd. NDA Current