Application 218571

Type: NDA
Sponsor: MILESTONE PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARDAMYST	ETRIPAMIL	SPRAY;NASAL	70MG	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
N218571-001	CARDAMYST	ETRIPAMIL	70MG	SPRAY / NASAL		RLD, RS	2025-12-12

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
N218571-001	10010522	2028-06-19	U-38		2026-01-06
N218571-001	10010523	2028-06-19		Drug substance	2026-01-06
N218571-001	9227918	2028-06-19		Drug product	2026-01-06
N218571-001	9463179	2028-06-19	U-4370		2026-01-06
N218571-001	10117848	2036-04-13	U-4370	Drug product	2026-01-06
N218571-001	12257224	2042-07-15	U-4370		2026-01-06

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N218571-001	NCE	2030-12-12

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	N218571-001	CARDAMYST	70MG	SPRAY / NASAL		RLD, RS	2025-12-12	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218571-001	CARDAMYST	70MG	SPRAY / NASAL		RLD, RS	2025-12-12	`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
2026-02-19 14:30 UTC	2026-02	N218571-001	10010522	2028-06-19	U-38		2026-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218571-001	10010523	2028-06-19		Drug substance	2026-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218571-001	9227918	2028-06-19		Drug product	2026-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218571-001	9463179	2028-06-19	U-4370		2026-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218571-001	10117848	2036-04-13	U-4370	Drug product	2026-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N218571-001	12257224	2042-07-15	U-4370		2026-01-06	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218571-001	10010522	2028-06-19	U-38		2026-01-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218571-001	10010523	2028-06-19		Drug substance	2026-01-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218571-001	9227918	2028-06-19		Drug product	2026-01-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218571-001	9463179	2028-06-19	U-4370		2026-01-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218571-001	10117848	2036-04-13	U-4370	Drug product	2026-01-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218571-001	12257224	2042-07-15	U-4370		2026-01-06	`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	N218571-001	NCE	2030-12-12	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N218571-001	NCE	2030-12-12	`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
Cardamyst	ETRIPAMIL	Milestone Pharmaceuticals USA, Inc.	a92170b9-4f93-4b83-b2cd-cb85c52821cd	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 218571 application number: NDA218571

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84829	ORIG	2026-01-23
84422	ORIG	2025-12-15
84414	ORIG	2025-12-15