Application 204958

Type: NDA
Sponsor: CHIESI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KENGREAL	CANGRELOR	POWDER;INTRAVENOUS	50MG/VIAL	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204958-001	KENGREAL	CANGRELOR	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2015-06-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204958-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204958-001	9925265	2029-05-13	U-2260		2018-04-11
N204958-001	9427448	2030-11-10	U-1926		2016-12-09
N204958-001	8680052	2033-03-09	U-2979		2015-07-16
N204958-001	10039780	2035-07-10	U-2260		2018-08-30
N204958-001	9295687	2035-07-10		Drug product	2016-03-29
N204958-001	9439921	2035-07-10		Drug product	2016-12-09
N204958-001	9700575	2035-07-10		Drug product	2017-07-28

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 2 · 42 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
2026-08-18 06:07:40	2026-07	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2015-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2015-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS	AP	RLD, RS	2015-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204958-001	KENGREAL	50MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2015-06-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N204958-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204958-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204958-001	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204958-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 322 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	N204958-001	9925265	2029-05-13	U-2260		2018-04-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204958-001	9427448	2030-11-10	U-1926		2016-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204958-001	8680052	2033-03-09	U-2979		2015-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204958-001	10039780	2035-07-10	U-2260		2018-08-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204958-001	9295687	2035-07-10		Drug product	2016-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204958-001	9439921	2035-07-10		Drug product	2016-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204958-001	9700575	2035-07-10		Drug product	2017-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204958-001	9925265	2029-05-13	U-2260		2018-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204958-001	9427448	2030-11-10	U-1926		2016-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204958-001	8680052	2033-03-09	U-2979		2015-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204958-001	10039780	2035-07-10	U-2260		2018-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204958-001	9295687	2035-07-10		Drug product	2016-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204958-001	9439921	2035-07-10		Drug product	2016-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204958-001	9700575	2035-07-10		Drug product	2017-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204958-001	9925265	2029-05-13	U-2260		2018-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204958-001	9427448	2030-11-10	U-1926		2016-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204958-001	8680052	2033-03-09	U-2979		2015-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204958-001	10039780	2035-07-10	U-2260		2018-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204958-001	9295687	2035-07-10		Drug product	2016-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204958-001	9439921	2035-07-10		Drug product	2016-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204958-001	9700575	2035-07-10		Drug product	2017-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204958-001	9925265	2029-05-13	U-2260		2018-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204958-001	9427448	2030-11-10	U-1926		2016-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204958-001	8680052	2033-03-09	U-2979		2015-07-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204958-001	10039780	2035-07-10	U-2260		2018-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204958-001	9295687	2035-07-10		Drug product	2016-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204958-001	9439921	2035-07-10		Drug product	2016-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204958-001	9700575	2035-07-10		Drug product	2017-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204958-001	9925265	2029-05-13	U-2260		2018-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204958-001	9427448	2030-11-10	U-1926		2016-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204958-001	8680052	2033-03-09	U-2979		2015-07-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204958-001	10039780	2035-07-10	U-2260		2018-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204958-001	9295687	2035-07-10		Drug product	2016-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204958-001	9439921	2035-07-10		Drug product	2016-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204958-001	9700575	2035-07-10		Drug product	2017-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204958-001	9925265	2029-05-13	U-2260		2018-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204958-001	9427448	2030-11-10	U-1926		2016-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204958-001	8680052	2033-03-09	U-2979		2015-07-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204958-001	10039780	2035-07-10	U-2260		2018-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204958-001	9295687	2035-07-10		Drug product	2016-03-29	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N204958-001	NCE	2020-06-22	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N204958-001	NCE	2020-06-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204958-001	NCE	2020-06-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204958-001	NCE	2020-06-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204958-001	NCE	2020-06-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204958-001	NCE	2020-06-22	`ea99ee380514…`

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
KENGREAL	CANGRELOR	Chiesi USA, Inc.	88b434fa-8891-4fd5-9d86-7ea64667c08f	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204958 application number: NDA204958 ndc (product): 10122-620

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10122-620	KENGREAL	cangrelor	Chiesi USA, Inc.	NDA	Current
10122-620	KENGREAL	cangrelor	Chiesi USA, Inc.	NDA	Current
10122-620	KENGREAL	cangrelor	Chiesi USA, Inc.	NDA	Current
10122-620	KENGREAL	cangrelor	Chiesi USA, Inc.	NDA	Current
65293-003	KENGREAL	cangrelor	The Medicines Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73345	SUPPL	2023-01-31
73303	SUPPL	2023-01-27
60663	SUPPL	2019-10-24
60650	SUPPL	2019-10-24
24485	ORIG	2015-07-29
22970	ORIG	2015-07-29
60122	SUPPL	2015-06-22
40428	ORIG	2015-06-22
10410	ORIG	2015-06-22