Application 022433

Type: NDA
Sponsor: ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BRILINTA	TICAGRELOR	TABLET;ORAL	90MG	Yes	Yes
002	BRILINTA	TICAGRELOR	TABLET;ORAL	60MG	Yes	No

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
N022433-001	BRILINTA	TICAGRELOR	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20
N022433-002	BRILINTA	TICAGRELOR	60MG	TABLET / ORAL	AB	RLD	2015-09-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N022433-001	AB
N022433-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022433-001	8425934	2030-04-17		Drug product	2013-05-20
N022433-001	8425934*PED	2030-10-17		Pediatric extension
N022433-001	10300065	2036-01-27	U-2541		2019-06-24
N022433-001	10300065	2036-01-27	U-2542		2019-06-24
N022433-001	10300065*PED	2036-07-27		Pediatric extension
N022433-002	8425934	2030-04-17		Drug product	2015-09-30
N022433-002	8425934*PED	2030-10-17		Pediatric extension
N022433-002	10300065	2036-01-27	U-2541		2019-06-24
N022433-002	10300065	2036-01-27	U-2542		2019-06-24
N022433-002	10300065*PED	2036-07-27		Pediatric extension

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022433-002	BRILINTA	60MG	TABLET / ORAL		RLD	2015-09-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022433-001	BRILINTA	90MG	TABLET / ORAL	AB	RLD, RS	2011-07-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022433-002	BRILINTA	60MG	TABLET / ORAL	AB	RLD	2015-09-03	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022433-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022433-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022433-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022433-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022433-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022433-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022433-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022433-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022433-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022433-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022433-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022433-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022433-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022433-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022433-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022433-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022433-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022433-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022433-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022433-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022433-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022433-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022433-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022433-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022433-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022433-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022433-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022433-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022433-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022433-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022433-001	AB	1	`053a50430f4f…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,050 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	N022433-001	8425934	2030-04-17		Drug product	2013-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-001	8425934*PED	2030-10-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-001	10300065	2036-01-27	U-2541		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-001	10300065	2036-01-27	U-2542		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-001	10300065*PED	2036-07-27		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	8425934	2030-04-17		Drug product	2015-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	8425934*PED	2030-10-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	10300065	2036-01-27	U-2541		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	10300065	2036-01-27	U-2542		2019-06-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022433-002	10300065*PED	2036-07-27		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-1936	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-1935	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-1937	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-1938	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-2988	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-2839	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276	2024-10-30	U-2838	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	RE46276*PED	2025-04-30		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	8425934	2030-04-17		Drug product	2013-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	8425934*PED	2030-10-17		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	10300065	2036-01-27	U-2541		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	10300065	2036-01-27	U-2542		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	10300065*PED	2036-07-27		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-1935	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-1938	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-1936	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-1937	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-2988	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-2839	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276	2024-10-30	U-2838	Drug substance, Drug product	2017-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	RE46276*PED	2025-04-30		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	8425934	2030-04-17		Drug product	2015-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	8425934*PED	2030-10-17		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	10300065	2036-01-27	U-2541		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	10300065	2036-01-27	U-2542		2019-06-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	10300065*PED	2036-07-27		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022433-001	RE46276*PED	2025-04-30		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-001	8425934	2030-04-17		Drug product	2013-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-001	8425934*PED	2030-10-17		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-001	10300065	2036-01-27	U-2541		2019-06-24	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 7 · 248 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	M-283	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-001	PED	2025-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	M-283	2025-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022433-002	PED	2025-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022433-001	M-283	2025-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-001	PED	2025-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-002	M-283	2025-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022433-002	PED	2025-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-001	M-283	2025-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-001	PED	2025-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-002	M-283	2025-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022433-002	PED	2025-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-001	M-283	2025-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-001	PED	2025-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-002	M-283	2025-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022433-002	PED	2025-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	I-848	2023-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	PED	2024-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	M-283	2025-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-001	PED	2025-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	I-848	2023-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	PED	2024-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	M-283	2025-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022433-002	PED	2025-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	I-848	2023-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	PED	2024-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	M-283	2025-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-001	PED	2025-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	I-848	2023-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	PED	2024-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	M-283	2025-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022433-002	PED	2025-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	I-848	2023-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	PED	2024-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	M-283	2025-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-001	PED	2025-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	I-848	2023-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	PED	2024-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	M-283	2025-05-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022433-002	PED	2025-11-09	`5bbf6a4d5a75…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRILINTA	TICAGRELOR	AstraZeneca Pharmaceuticals LP	f7b3f443-e83d-4bf2-0e96-023448fed9a8	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022433 application number: NDA022433 ndc (product): 0186-0776 ndc (product): 0186-0777
BRILINTA	TICAGRELOR	Cardinal Health 107, LLC	4f9bd52a-99a7-4606-92b4-456a917aabef	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022433 application number: NDA022433 ndc (product): 55154-9618
BRILINTA	TICAGRELOR	Aphena Pharma Solutions - Tennessee, LLC	1547e2b6-8858-178e-e063-6394a90abb23	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022433 application number: NDA022433

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceutica	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0776	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceutica	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
0186-0777	BRILINTA	Ticagrelor	AstraZeneca Pharmaceuticals LP	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health 107, LLC	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health 107, LLC	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current
55154-9618	BRILINTA	Ticagrelor	Cardinal Health	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85929	SUPPL	2026-05-18
85867	SUPPL	2026-05-11
80172	SUPPL	2024-11-05
80150	SUPPL	2024-11-05
80149	SUPPL	2024-11-05
77960	SUPPL	2024-03-25
77934	SUPPL	2024-03-25
71047	SUPPL	2022-05-11
71046	SUPPL	2022-05-11
71032	SUPPL	2022-05-10
68344	SUPPL	2021-08-11
68343	SUPPL	2021-08-11
68338	SUPPL	2021-08-11
66295	SUPPL	2021-02-18
66294	SUPPL	2021-02-18
66286	SUPPL	2021-02-18
65169	SUPPL	2020-11-09
65164	SUPPL	2020-11-09
65163	SUPPL	2020-11-09
64597	SUPPL	2020-09-17
64588	SUPPL	2020-09-17
64581	SUPPL	2020-09-16
63612	SUPPL	2020-06-18
63356	SUPPL	2020-06-01
63347	SUPPL	2020-05-29
63346	SUPPL	2020-05-29
60675	SUPPL	2019-10-25
60674	SUPPL	2019-10-25
60667	SUPPL	2019-10-25
58236	SUPPL	2019-04-05
58235	SUPPL	2019-04-05
58205	SUPPL	2019-04-04
52992	SUPPL	2018-03-15
52940	SUPPL	2018-03-13
45418	SUPPL	2016-09-29
45395	SUPPL	2016-09-26
45090	SUPPL	2016-08-22
44504	SUPPL	2016-07-28
7396	SUPPL	2016-07-26
38710	SUPPL	2016-07-25
42526	SUPPL	2016-02-10
38709	SUPPL	2015-09-23
7395	SUPPL	2015-09-22
38708	SUPPL	2015-09-08
7394	SUPPL	2015-09-08
17588	SUPPL	2015-03-27
7393	SUPPL	2015-03-27
17587	SUPPL	2013-12-17
7392	SUPPL	2013-12-17
7391	SUPPL	2013-10-31
29728	SUPPL	2013-04-01
17586	SUPPL	2013-04-01
17585	SUPPL	2013-01-30
7390	SUPPL	2013-01-28
42525	ORIG	2011-08-23
24307	ORIG	2011-08-23
38707	ORIG	2011-07-20
7389	ORIG	2011-07-20