Application 219835

Type: NDA
Sponsor: ARVINAS OPERATIONS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VEPPANU	VEPDEGESTRANT	TABLET;ORAL	100MG	Yes	No
002	VEPPANU	VEPDEGESTRANT	TABLET;ORAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N219835-001	VEPPANU	VEPDEGESTRANT	100MG	TABLET / ORAL		RLD	2026-05-01
N219835-002	VEPPANU	VEPDEGESTRANT	200MG	TABLET / ORAL		RLD, RS	2026-05-01

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219835-001	10899742	2037-12-01	U-4278		2026-05-29
N219835-001	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29
N219835-001	10647698	2038-01-30		Drug substance, Drug product	2026-05-29
N219835-002	10899742	2037-12-01	U-4278		2026-05-29
N219835-002	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29
N219835-002	10647698	2038-01-30		Drug substance, Drug product	2026-05-29

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219835-001	NCE	2031-05-01
N219835-002	NCE	2031-05-01

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
2026-09-14 22:38:34	2026-08	N219835-001	VEPPANU	100MG	TABLET / ORAL	RLD	2026-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	VEPPANU	200MG	TABLET / ORAL	RLD, RS	2026-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219835-001	VEPPANU	100MG	TABLET / ORAL	RLD	2026-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	VEPPANU	200MG	TABLET / ORAL	RLD, RS	2026-05-01	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	VEPPANU	100MG	TABLET / ORAL	RLD	2026-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	VEPPANU	200MG	TABLET / ORAL	RLD, RS	2026-05-01	`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
2026-09-14 22:38:34	2026-08	N219835-001	10899742	2037-12-01	U-4278		2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-001	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-001	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	10899742	2037-12-01	U-4278		2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219835-001	10899742	2037-12-01	U-4278		2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-001	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-001	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	10899742	2037-12-01	U-4278		2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	10899742	2037-12-01	U-4278		2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	10899742	2037-12-01	U-4278		2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219835-001	NCE	2031-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	NCE	2031-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219835-001	NCE	2031-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	NCE	2031-05-01	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	NCE	2031-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	NCE	2031-05-01	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VEPPANU	VEPDEGESTRANT	Rigel Pharmaceuticals, Inc.	484e21ba-8fe1-4c6d-b923-8ba4cf5b2f20	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219835 application number: NDA219835
VEPPANU	VEPDEGESTRANT	Arvinas Operations, Inc.	751e18d5-1d41-4b67-b1f3-10272ca5312d	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219835 application number: NDA219835

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85825	ORIG	2026-05-04