Application 216387

Type: NDA
Sponsor: ASTRAZENECA UK LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CALQUENCE	ACALABRUTINIB	TABLET, FILM COATED	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N216387-001	CALQUENCE	ACALABRUTINIB MALEATE	EQ 100MG BASE	TABLET / ORAL		RLD, RS	2022-08-03

Orange Book patents#

Current patent rows page 1 of 1 · 29 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216387-001	7459554	2026-11-24		Drug substance	2022-09-01
N216387-001	10239883	2032-07-11	U-2666		2022-09-01
N216387-001	10239883	2032-07-11	U-2668		2022-09-01
N216387-001	9290504	2032-07-11		Drug substance, Drug product	2022-09-01
N216387-001	9758524	2032-07-11	U-2145		2022-09-01
N216387-001	9758524	2032-07-11	U-4108		2022-09-01
N216387-001	10272083	2035-01-21	U-2519		2022-09-01
N216387-001	10272083	2035-01-21	U-2682		2022-09-01
N216387-001	10272083	2035-01-21	U-2683		2022-09-01
N216387-001	10272083	2035-01-21	U-2684		2022-09-01
N216387-001	10272083	2035-01-21	U-2685		2022-09-01
N216387-001	10272083	2035-01-21	U-2686		2022-09-01
N216387-001	10272083	2035-01-21	U-2687		2022-09-01
N216387-001	10272083	2035-01-21	U-4109		2022-09-01
N216387-001	11771696	2035-01-21	U-3710		2023-10-30
N216387-001	11166951	2035-08-11	U-4426		2026-03-18
N216387-001	11166951	2035-08-11	U-4427		2026-03-18
N216387-001	11166951	2035-08-11	U-4428		2026-03-18
N216387-001	11166951	2035-08-11	U-4429		2026-03-18
N216387-001	11166951	2035-08-11	U-4430		2026-03-18
N216387-001	11166951	2035-08-11	U-4431		2026-03-18
N216387-001	11059829	2036-07-01	U-2145	Drug substance, Drug product	2022-09-01
N216387-001	11059829	2036-07-01	U-2666	Drug substance, Drug product	2022-09-01
N216387-001	11059829	2036-07-01	U-2667	Drug substance, Drug product	2022-09-01
N216387-001	11059829	2036-07-01	U-2668	Drug substance, Drug product	2022-09-01
N216387-001	11059829	2036-07-01	U-2669	Drug substance, Drug product	2022-09-01
N216387-001	11059829	2036-07-01	U-2670	Drug substance, Drug product	2022-09-01
N216387-001	11059829	2036-07-01	U-2671	Drug substance, Drug product	2022-09-01
N216387-001	11059829	2036-07-01	U-4108	Drug substance, Drug product	2022-09-01

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216387-001	I-960	2028-01-16
N216387-001	D-200	2029-02-19

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	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216387-001	CALQUENCE	EQ 100MG BASE	TABLET / ORAL	RLD, RS	2022-08-03	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 555 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	N216387-001	7459554	2026-11-24		Drug substance	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10239883	2032-07-11	U-2666		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10239883	2032-07-11	U-2668		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	9290504	2032-07-11		Drug substance, Drug product	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	9758524	2032-07-11	U-4108		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	9758524	2032-07-11	U-2145		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10272083	2035-01-21	U-4109		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10272083	2035-01-21	U-2519		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10272083	2035-01-21	U-2682		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10272083	2035-01-21	U-2683		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10272083	2035-01-21	U-2684		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10272083	2035-01-21	U-2685		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10272083	2035-01-21	U-2686		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	10272083	2035-01-21	U-2687		2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	11771696	2035-01-21	U-3710		2023-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	11059829	2036-07-01	U-4108	Drug substance, Drug product	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	11059829	2036-07-01	U-2145	Drug substance, Drug product	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	11059829	2036-07-01	U-2671	Drug substance, Drug product	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	11059829	2036-07-01	U-2670	Drug substance, Drug product	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	11059829	2036-07-01	U-2669	Drug substance, Drug product	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	11059829	2036-07-01	U-2668	Drug substance, Drug product	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	11059829	2036-07-01	U-2667	Drug substance, Drug product	2022-09-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216387-001	11059829	2036-07-01	U-2666	Drug substance, Drug product	2022-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	7459554	2026-11-24		Drug substance	2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10239883	2032-07-11	U-2666		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10239883	2032-07-11	U-2668		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	9290504	2032-07-11		Drug substance, Drug product	2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	9758524	2032-07-11	U-4108		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	9758524	2032-07-11	U-2145		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10272083	2035-01-21	U-4109		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10272083	2035-01-21	U-2519		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10272083	2035-01-21	U-2682		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10272083	2035-01-21	U-2683		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10272083	2035-01-21	U-2684		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10272083	2035-01-21	U-2685		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10272083	2035-01-21	U-2686		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	10272083	2035-01-21	U-2687		2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	11771696	2035-01-21	U-3710		2023-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	11059829	2036-07-01	U-4108	Drug substance, Drug product	2022-09-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	11059829	2036-07-01	U-2145	Drug substance, Drug product	2022-09-01	`31067a03dcf5…`

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	N216387-001	I-960	2028-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216387-001	I-960	2028-01-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216387-001	I-960	2028-01-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216387-001	I-960	2028-01-16	`fd3edfee7708…`
2023-01-26 05:58 UTC	2023-01	N216387-001	NCE	2022-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216387-001	NCE	2022-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216387-001	NCE	2022-10-31	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216387-001	I-960	2028-01-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216387-001	D-200	2029-02-19	`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
CALQUENCE	ACALABRUTINIB	AstraZeneca Pharmaceuticals LP	b1409184-3267-4d8c-8f17-4e01f69828b1	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216387 application number: NDA216387 ndc (product): 0310-3512

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-3512	CALQUENCE	acalabrutinib	AstraZeneca Pharmaceuticals LP	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85132	SUPPL	2026-02-24
85103	SUPPL	2026-02-23
80874	SUPPL	2025-01-17
80865	SUPPL	2025-01-17
78733	SUPPL	2024-07-02
78700	SUPPL	2024-06-06
74314	ORIG	2023-05-19
74313	ORIG	2023-05-19
71734	ORIG	2022-08-05
71733	ORIG	2022-08-05
71724	ORIG	2022-08-05