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 43.

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	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 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209449-001	NITYR	2MG	TABLET / ORAL	RLD	2017-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209449-002	NITYR	5MG	TABLET / ORAL	RLD	2017-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209449-003	NITYR	10MG	TABLET / ORAL	RLD, RS	2017-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209449-004	HARLIKU	2MG	TABLET / ORAL	RLD, RS	2025-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209449-001	NITYR	2MG	TABLET / ORAL	RLD	2017-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209449-002	NITYR	5MG	TABLET / ORAL	RLD	2017-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209449-003	NITYR	10MG	TABLET / ORAL	RLD, RS	2017-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209449-004	HARLIKU	2MG	TABLET / ORAL	RLD, RS	2025-06-10	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209449-001	10328029	2035-01-05	U-1836	Drug product	2019-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209449-002	10328029	2035-01-05	U-1836	Drug product	2019-07-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209449-003	10328029	2035-01-05	U-1836	Drug product	2019-07-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209449-001	10328029	2035-01-05	U-1836	Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209449-002	10328029	2035-01-05	U-1836	Drug product	2019-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209449-003	10328029	2035-01-05	U-1836	Drug product	2019-07-17	`caaa826d4ba7…`
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…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N209449-004	ODE-529	2032-06-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209449-004	ODE-529	2032-06-10	`caaa826d4ba7…`
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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITYR	NITISINONE	Cycle Pharmaceuticals Ltd.	00fd1905-27e4-420e-8dc5-a69e4ddc1526	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209449 application number: NDA209449 ndc (product): 70709-005 ndc (product): 70709-002 ndc (product): 70709-000
HARLIKU	NITISINONE	Cycle Pharmaceuticals Ltd.	7cf67e24-d46b-4376-bbd0-0b973c406d0d	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209449 application number: NDA209449

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82546	SUPPL	2025-06-12
82538	SUPPL	2025-06-11
77245	SUPPL	2024-01-19
77243	SUPPL	2024-01-19
64519	SUPPL	2020-09-04
56825	SUPPL	2018-12-20
56476	SUPPL	2018-11-15
56312	SUPPL	2018-11-06
50202	ORIG	2017-10-27
49120	ORIG	2017-07-28
49096	ORIG	2017-07-27
51409	ORIG	1900-01-01
51408	ORIG	1900-01-01