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 1.

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
2026-02-19 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 7 · 278 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	N218197-001	10059714	2028-10-10		Drug substance, Drug product	2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-001	10654855	2028-10-10	U-3762		2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-001	11760760	2028-10-10	U-3762		2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-001	12252495	2028-10-10	U-3762		2025-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-001	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-001	10039766	2033-04-16	U-3762		2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-001	9487525	2033-04-16		Drug substance, Drug product	2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-002	10059714	2028-10-10		Drug substance, Drug product	2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-002	10654855	2028-10-10	U-3762		2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-002	11760760	2028-10-10	U-3762		2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-002	12252495	2028-10-10	U-3762		2025-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-002	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-002	10039766	2033-04-16	U-3762		2023-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218197-002	9487525	2033-04-16		Drug substance, Drug product	2023-12-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	8809336	2025-10-25	U-3762		2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	9006430	2025-10-25		Drug product	2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	10059714	2028-10-10		Drug substance, Drug product	2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	10654855	2028-10-10	U-3762		2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	11760760	2028-10-10	U-3762		2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	12252495	2028-10-10	U-3762		2025-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	10039766	2033-04-16	U-3762		2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-001	9487525	2033-04-16		Drug substance, Drug product	2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	8809336	2025-10-25	U-3762		2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	9006430	2025-10-25		Drug product	2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	10059714	2028-10-10		Drug substance, Drug product	2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	10654855	2028-10-10	U-3762		2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	11760760	2028-10-10	U-3762		2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	12252495	2028-10-10	U-3762		2025-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	10039766	2033-04-16	U-3762		2023-12-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N218197-002	9487525	2033-04-16		Drug substance, Drug product	2023-12-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N218197-001	8809336	2025-10-25	U-3762		2023-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218197-001	9006430	2025-10-25		Drug product	2023-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218197-001	10059714	2028-10-10		Drug substance, Drug product	2023-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218197-001	10654855	2028-10-10	U-3762		2023-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218197-001	11760760	2028-10-10	U-3762		2023-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218197-001	12252495	2028-10-10	U-3762		2025-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218197-001	8101623	2030-03-10	U-3762	Drug substance, Drug product	2023-12-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N218197-001	10039766	2033-04-16	U-3762		2023-12-13	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218197-001	NCE	2028-11-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218197-001	I-991	2029-06-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218197-002	NCE	2028-11-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218197-002	I-991	2029-06-12	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRUQAP	CAPIVASERTIB	AstraZeneca Pharmaceuticals LP	d698c106-2322-401e-b738-cbd83c843ecf	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218197 application number: NDA218197

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