Application 219008

Type: NDA
Sponsor: JANSSEN BIOTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LAZCLUZE	LAZERTINIB MESYLATE	TABLET;ORAL	EQ 80MG BASE	Yes	No
002	LAZCLUZE	LAZERTINIB MESYLATE	TABLET;ORAL	EQ 240MG BASE	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
N219008-001	LAZCLUZE	LAZERTINIB MESYLATE	EQ 80MG BASE	TABLET / ORAL		RLD	2024-08-19
N219008-002	LAZCLUZE	LAZERTINIB MESYLATE	EQ 240MG BASE	TABLET / ORAL		RLD, RS	2024-08-19

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219008-001	9593098	2035-10-13	U-3985	Drug substance, Drug product	2024-09-17
N219008-001	11453656	2038-04-18		Drug substance, Drug product	2024-09-17
N219008-001	11981659	2038-04-18	U-3985		2024-09-17
N219008-001	12318390	2038-04-18		Drug product	2025-10-17
N219008-001	12599606	2040-05-14	U-4512		2026-05-22
N219008-001	11879013	2040-05-21	U-3985		2024-09-17
N219008-001	12138351	2041-04-13		Drug product	2025-02-13
N219008-001	11850248	2041-08-01	U-3985		2024-09-17
N219008-002	9593098	2035-10-13	U-3985	Drug substance, Drug product	2024-09-17
N219008-002	11453656	2038-04-18		Drug substance, Drug product	2024-09-17
N219008-002	11981659	2038-04-18	U-3985		2024-09-17
N219008-002	12318390	2038-04-18		Drug product	2025-10-17
N219008-002	12599606	2040-05-14	U-4511		2026-05-12
N219008-002	11879013	2040-05-21	U-3985		2024-09-17
N219008-002	12138351	2041-04-13		Drug product	2025-02-13
N219008-002	11850248	2041-08-01	U-3985		2024-09-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219008-001	NCE	2029-08-19
N219008-002	NCE	2029-08-19

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	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219008-001	LAZCLUZE	EQ 80MG BASE	TABLET / ORAL	RLD	2024-08-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219008-002	LAZCLUZE	EQ 240MG BASE	TABLET / ORAL	RLD, RS	2024-08-19	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 118 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	N219008-001	9593098	2035-10-13	U-3985	Drug substance, Drug product	2024-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-001	11453656	2038-04-18		Drug substance, Drug product	2024-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-001	11981659	2038-04-18	U-3985		2024-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-001	12318390	2038-04-18		Drug product	2025-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-001	11879013	2040-05-21	U-3985		2024-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-001	12138351	2041-04-13		Drug product	2025-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-001	11850248	2041-08-01	U-3985		2024-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-002	9593098	2035-10-13	U-3985	Drug substance, Drug product	2024-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-002	11453656	2038-04-18		Drug substance, Drug product	2024-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-002	11981659	2038-04-18	U-3985		2024-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-002	12318390	2038-04-18		Drug product	2025-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-002	11879013	2040-05-21	U-3985		2024-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-002	12138351	2041-04-13		Drug product	2025-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-002	11850248	2041-08-01	U-3985		2024-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-001	9593098	2035-10-13	U-3985	Drug substance, Drug product	2024-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-001	11453656	2038-04-18		Drug substance, Drug product	2024-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-001	11981659	2038-04-18	U-3985		2024-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-001	12318390	2038-04-18		Drug product	2025-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-001	11879013	2040-05-21	U-3985		2024-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-001	12138351	2041-04-13		Drug product	2025-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-001	11850248	2041-08-01	U-3985		2024-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-002	9593098	2035-10-13	U-3985	Drug substance, Drug product	2024-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-002	11453656	2038-04-18		Drug substance, Drug product	2024-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-002	11981659	2038-04-18	U-3985		2024-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-002	12318390	2038-04-18		Drug product	2025-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-002	11879013	2040-05-21	U-3985		2024-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-002	12138351	2041-04-13		Drug product	2025-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-002	11850248	2041-08-01	U-3985		2024-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219008-001	9593098	2035-10-13	U-3985	Drug substance, Drug product	2024-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-001	11453656	2038-04-18		Drug substance, Drug product	2024-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-001	11981659	2038-04-18	U-3985		2024-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-001	11879013	2040-05-21	U-3985		2024-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-001	12138351	2041-04-13		Drug product	2025-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-001	11850248	2041-08-01	U-3985		2024-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-002	9593098	2035-10-13	U-3985	Drug substance, Drug product	2024-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-002	11453656	2038-04-18		Drug substance, Drug product	2024-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-002	11981659	2038-04-18	U-3985		2024-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-002	11879013	2040-05-21	U-3985		2024-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-002	12138351	2041-04-13		Drug product	2025-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-002	11850248	2041-08-01	U-3985		2024-09-17	`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	N219008-001	NCE	2029-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219008-002	NCE	2029-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-001	NCE	2029-08-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219008-002	NCE	2029-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219008-001	NCE	2029-08-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219008-002	NCE	2029-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219008-001	NCE	2029-08-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219008-002	NCE	2029-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219008-001	NCE	2029-08-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N219008-002	NCE	2029-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219008-001	NCE	2029-08-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N219008-002	NCE	2029-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219008-001	NCE	2029-08-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N219008-002	NCE	2029-08-19	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N219008-001	NCE	2029-08-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N219008-002	NCE	2029-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N219008-001	NCE	2029-08-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N219008-002	NCE	2029-08-19	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219008-001	NCE	2029-08-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219008-002	NCE	2029-08-19	`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
LAZCLUZE	LAZERTINIB	Janssen Biotech, Inc.	c417f9ee-2027-4ed5-92ad-3c19266de16c	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219008 application number: NDA219008

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85841	SUPPL	2026-05-05
85817	SUPPL	2026-05-04
84140	SUPPL	2025-11-12
84130	SUPPL	2025-11-10
83108	SUPPL	2025-08-18
79628	ORIG	2024-09-16
79450	ORIG	2024-08-20
79439	ORIG	2024-08-20