Application 022075

Type: NDA
Sponsor: KYOWA KIRIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NOURIANZ	ISTRADEFYLLINE	TABLET;ORAL	20MG	Yes	No
002	NOURIANZ	ISTRADEFYLLINE	TABLET;ORAL	40MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022075-001	NOURIANZ	ISTRADEFYLLINE	20MG	TABLET / ORAL		RLD	2019-08-27
N022075-002	NOURIANZ	ISTRADEFYLLINE	40MG	TABLET / ORAL		RLD, RS	2019-08-27

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022075-001	8318201	2027-09-05		Drug product	2019-09-25
N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25
N022075-002	8318201	2027-09-05		Drug product	2019-09-25
N022075-002	7727993	2028-01-28	U-2623	Drug product	2019-09-25

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022075-001	NOURIANZ	20MG	TABLET / ORAL	RLD	2019-08-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022075-002	NOURIANZ	40MG	TABLET / ORAL	RLD, RS	2019-08-27	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 270 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022075-001	8318201	2027-09-05		Drug product	2019-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022075-002	8318201	2027-09-05		Drug product	2019-09-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022075-002	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022075-001	8318201	2027-09-05		Drug product	2019-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022075-002	8318201	2027-09-05		Drug product	2019-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022075-002	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022075-001	8318201	2027-09-05		Drug product	2019-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022075-002	8318201	2027-09-05		Drug product	2019-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022075-002	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022075-001	8318201	2027-09-05		Drug product	2019-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022075-002	8318201	2027-09-05		Drug product	2019-09-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022075-002	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022075-001	8318201	2027-09-05		Drug product	2019-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022075-002	8318201	2027-09-05		Drug product	2019-09-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022075-002	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022075-001	8318201	2027-09-05		Drug product	2019-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022075-002	8318201	2027-09-05		Drug product	2019-09-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022075-002	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-001	7541363	2024-11-13		Drug substance, Drug product	2019-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-001	8318201	2027-09-05		Drug product	2019-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-002	7541363	2024-11-13		Drug substance, Drug product	2019-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-002	8318201	2027-09-05		Drug product	2019-09-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-002	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-001	7541363	2024-11-13		Drug substance, Drug product	2019-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-001	8318201	2027-09-05		Drug product	2019-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-002	7541363	2024-11-13		Drug substance, Drug product	2019-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-002	8318201	2027-09-05		Drug product	2019-09-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-002	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022075-001	7541363	2024-11-13		Drug substance, Drug product	2019-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022075-001	8318201	2027-09-05		Drug product	2019-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022075-001	7727993	2028-01-28	U-2623	Drug product	2019-09-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022075-002	7541363	2024-11-13		Drug substance, Drug product	2019-09-25	`5bbf6a4d5a75…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-001	NCE	2024-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022075-002	NCE	2024-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-001	NCE	2024-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022075-002	NCE	2024-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022075-001	NCE	2024-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022075-002	NCE	2024-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022075-001	NCE	2024-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022075-002	NCE	2024-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022075-001	NCE	2024-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022075-002	NCE	2024-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022075-001	NCE	2024-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022075-002	NCE	2024-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022075-001	NCE	2024-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022075-002	NCE	2024-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022075-001	NCE	2024-08-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022075-002	NCE	2024-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022075-001	NCE	2024-08-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022075-002	NCE	2024-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022075-001	NCE	2024-08-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022075-002	NCE	2024-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022075-001	NCE	2024-08-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022075-002	NCE	2024-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022075-001	NCE	2024-08-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022075-002	NCE	2024-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022075-001	NCE	2024-08-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022075-002	NCE	2024-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022075-001	NCE	2024-08-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022075-002	NCE	2024-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022075-001	NCE	2024-08-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022075-002	NCE	2024-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022075-001	NCE	2024-08-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022075-002	NCE	2024-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022075-001	NCE	2024-08-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022075-002	NCE	2024-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022075-001	NCE	2024-08-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022075-002	NCE	2024-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022075-001	NCE	2024-08-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022075-002	NCE	2024-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022075-001	NCE	2024-08-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022075-002	NCE	2024-08-27	`3f01610625f2…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NOURIANZ	ISTRADEFYLLINE	Kyowa Kirin, Inc.	a7d008cb-b273-4049-a5d2-9c6902910d58	2025-05-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022075 application number: NDA022075 ndc (product): 42747-602 ndc (product): 42747-604

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42747-602	NOURIANZ	istradefylline	Kyowa Kirin, Inc.	NDA	Current
42747-602	NOURIANZ	istradefylline	Kyowa Kirin, Inc.	NDA	Current
42747-602	NOURIANZ	istradefylline	Kyowa Kirin, Inc.	NDA	Current
42747-604	NOURIANZ	istradefylline	Kyowa Kirin, Inc.	NDA	Current
42747-604	NOURIANZ	istradefylline	Kyowa Kirin, Inc.	NDA	Current
42747-604	NOURIANZ	istradefylline	Kyowa Kirin, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60257	ORIG	2019-10-07
59869	ORIG	2019-08-29
59861	ORIG	2019-08-27