Application 220152

Type: NDA
Sponsor: VANDA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEREUS	TRADIPITANT	CAPSULE;ORAL	85MG	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
N220152-001	NEREUS	TRADIPITANT	85MG	CAPSULE / ORAL		RLD, RS	2025-12-30

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N220152-001	10772880	2036-03-04	U-4396	2026-01-28
N220152-001	10821099	2036-03-04	U-4396	2026-01-28
N220152-001	11324735	2036-03-04	U-4396	2026-01-28
N220152-001	12318375	2036-08-09	U-4396	2026-01-28

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N220152-001	NCE	2030-12-30

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
2026-02-19 14:30 UTC	2026-02	N220152-001	NEREUS	85MG	CAPSULE / ORAL		RLD, RS	2025-12-30	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220152-001	NEREUS	85MG	CAPSULE / ORAL		RLD, RS	2025-12-30	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N220152-001	10772880	2036-03-04	U-4396	2026-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220152-001	10821099	2036-03-04	U-4396	2026-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220152-001	11324735	2036-03-04	U-4396	2026-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220152-001	12318375	2036-08-09	U-4396	2026-01-28	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220152-001	10772880	2036-03-04	U-4396	2026-01-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220152-001	10821099	2036-03-04	U-4396	2026-01-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220152-001	11324735	2036-03-04	U-4396	2026-01-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220152-001	12318375	2036-08-09	U-4396	2026-01-28	`a50c72e98297…`

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	N220152-001	NCE	2030-12-30	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220152-001	NCE	2030-12-30	`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
NEREUS	TRADIPITANT	Vanda Pharmaceuticals Inc.	1a021ebd-16ac-4354-b4b2-1c3950c091e5	2026-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 220152 application number: NDA220152

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84880	ORIG	2026-01-29
84667	ORIG	2026-01-06
84624	ORIG	2025-12-31