Application 219042

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HERNEXEOS	ZONGERTINIB	TABLET;ORAL	60MG	Yes	Yes

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
N219042-001	HERNEXEOS	ZONGERTINIB	60MG	TABLET / ORAL		RLD, RS	2025-08-08

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219042-001	12171739	2026-11-15		Drug substance, Drug product	2025-08-25
N219042-001	11608343	2041-07-21	U-4245	Drug substance, Drug product	2025-08-25

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219042-001	NCE	2030-08-08

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N219042-001	HERNEXEOS	60MG	TABLET / ORAL		RLD, RS	2025-08-08	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N219042-001	12171739	2026-11-15		Drug substance, Drug product	2025-08-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N219042-001	11608343	2041-07-21	U-4245	Drug substance, Drug product	2025-08-25	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N219042-001	NCE	2030-08-08	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
HERNEXEOS	ZONGERTINIB	Boehringer Ingelheim Pharmaceuticals, Inc.	d3fabf12-354e-4e5c-b5de-20fdb579b783	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219042 application number: NDA219042

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85198	SUPPL	2026-03-02
85197	SUPPL	2026-03-02
83308	ORIG	2025-09-09
83091	ORIG	2025-08-12
83070	ORIG	2025-08-11