Application 218197

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRUQAP	CAPIVASERTIB	TABLET;ORAL	160MG	Yes	No
002	TRUQAP	CAPIVASERTIB	TABLET;ORAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N218197-001	TRUQAP	CAPIVASERTIB	160MG	TABLET / ORAL		RLD	2023-11-16
N218197-002	TRUQAP	CAPIVASERTIB	200MG	TABLET / ORAL		RLD, RS	2023-11-16

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N218197-001	10059714	2028-10-10		Drug substance, Drug product	2023-12-13
N218197-001	10654855	2028-10-10	U-3762		2023-12-13
N218197-001	11236095	2028-10-10	U-4559		2026-07-07
N218197-001	11760760	2028-10-10	U-3762		2023-12-13
N218197-001	12252495	2028-10-10	U-3762		2025-03-28
N218197-001	9492453	2028-10-10	U-4559		2026-07-07
N218197-001	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13
N218197-001	10039766	2033-04-16	U-3762		2023-12-13
N218197-001	10039766	2033-04-16	U-4559		2023-12-13
N218197-001	9487525	2033-04-16		Drug substance, Drug product	2023-12-13
N218197-002	10059714	2028-10-10		Drug substance, Drug product	2023-12-13
N218197-002	10654855	2028-10-10	U-3762		2023-12-13
N218197-002	11236095	2028-10-10	U-4559		2026-07-07
N218197-002	11760760	2028-10-10	U-3762		2023-12-13
N218197-002	12252495	2028-10-10	U-3762		2025-03-28
N218197-002	9492453	2028-10-10	U-4559		2026-07-07
N218197-002	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13
N218197-002	10039766	2033-04-16	U-3762		2023-12-13
N218197-002	10039766	2033-04-16	U-4559		2023-12-13
N218197-002	9487525	2033-04-16		Drug substance, Drug product	2023-12-13

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218197-001	NCE	2028-11-16
N218197-001	I-991	2029-06-12
N218197-002	NCE	2028-11-16
N218197-002	I-991	2029-06-12

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.

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	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218197-001	TRUQAP	160MG	TABLET / ORAL	RLD	2023-11-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218197-002	TRUQAP	200MG	TABLET / ORAL	RLD, RS	2023-11-16	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 318 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	N218197-001	10059714	2028-10-10		Drug substance, Drug product	2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	10654855	2028-10-10	U-3762		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	11236095	2028-10-10	U-4559		2026-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	11760760	2028-10-10	U-3762		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	12252495	2028-10-10	U-3762		2025-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	9492453	2028-10-10	U-4559		2026-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	10039766	2033-04-16	U-3762		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	10039766	2033-04-16	U-4559		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	9487525	2033-04-16		Drug substance, Drug product	2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	10059714	2028-10-10		Drug substance, Drug product	2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	10654855	2028-10-10	U-3762		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	11236095	2028-10-10	U-4559		2026-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	11760760	2028-10-10	U-3762		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	12252495	2028-10-10	U-3762		2025-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	9492453	2028-10-10	U-4559		2026-07-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	10039766	2033-04-16	U-3762		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	10039766	2033-04-16	U-4559		2023-12-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	9487525	2033-04-16		Drug substance, Drug product	2023-12-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218197-001	10059714	2028-10-10		Drug substance, Drug product	2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	10654855	2028-10-10	U-3762		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	11236095	2028-10-10	U-4559		2026-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	11760760	2028-10-10	U-3762		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	12252495	2028-10-10	U-3762		2025-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	9492453	2028-10-10	U-4559		2026-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	10039766	2033-04-16	U-3762		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	10039766	2033-04-16	U-4559		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	9487525	2033-04-16		Drug substance, Drug product	2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	10059714	2028-10-10		Drug substance, Drug product	2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	10654855	2028-10-10	U-3762		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	11236095	2028-10-10	U-4559		2026-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	11760760	2028-10-10	U-3762		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	12252495	2028-10-10	U-3762		2025-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	9492453	2028-10-10	U-4559		2026-07-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	10039766	2033-04-16	U-3762		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	10039766	2033-04-16	U-4559		2023-12-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	9487525	2033-04-16		Drug substance, Drug product	2023-12-13	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N218197-001	NCE	2028-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-001	I-991	2029-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	NCE	2028-11-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N218197-002	I-991	2029-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N218197-001	NCE	2028-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-001	I-991	2029-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	NCE	2028-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N218197-002	I-991	2029-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N218197-001	NCE	2028-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-002	NCE	2028-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	NCE	2028-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	NCE	2028-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218197-001	NCE	2028-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218197-002	NCE	2028-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218197-001	NCE	2028-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N218197-002	NCE	2028-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218197-001	NCE	2028-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N218197-002	NCE	2028-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218197-001	NCE	2028-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N218197-002	NCE	2028-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218197-001	NCE	2028-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N218197-002	NCE	2028-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218197-001	NCE	2028-11-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N218197-002	NCE	2028-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218197-001	NCE	2028-11-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N218197-002	NCE	2028-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N218197-001	NCE	2028-11-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N218197-002	NCE	2028-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218197-001	NCE	2028-11-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N218197-002	NCE	2028-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218197-001	NCE	2028-11-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N218197-002	NCE	2028-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218197-001	NCE	2028-11-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N218197-002	NCE	2028-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N218197-001	NCE	2028-11-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N218197-002	NCE	2028-11-16	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N218197-001	NCE	2028-11-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N218197-002	NCE	2028-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N218197-001	NCE	2028-11-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N218197-002	NCE	2028-11-16	`1c564ffb4f44…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84183	SUPPL	2025-11-18
84175	SUPPL	2025-11-17
81263	SUPPL	2025-02-18
81258	SUPPL	2025-02-14
79729	SUPPL	2024-09-24
79709	SUPPL	2024-09-24
76873	ORIG	2023-12-15
76619	ORIG	2023-11-17
76598	ORIG	2023-11-17