Application 219500

Type: NDA
Sponsor: CORSTASIS THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ENBUMYST	BUMETANIDE	SPRAY;NASAL	0.5MG/SPRAY	Yes	Yes

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

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
N219500-001	ENBUMYST	BUMETANIDE	0.5MG/SPRAY	SPRAY / NASAL		RLD, RS	2025-09-12

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219500-001	11123319	2040-12-04		Drug product	2025-10-03
N219500-001	11260038	2040-12-04	U-4279		2025-10-03
N219500-001	12329731	2040-12-04	U-4279	Drug product	2025-10-03
N219500-001	12558330	2045-05-14	U-4279	Drug product	2026-03-25

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	N219500-001	ENBUMYST	0.5MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-09-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219500-001	ENBUMYST	0.5MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-09-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219500-001	ENBUMYST	0.5MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219500-001	ENBUMYST	0.5MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-09-12	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219500-001	ENBUMYST	0.5MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-09-12	`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
2026-09-14 22:38:34	2026-08	N219500-001	11123319	2040-12-04		Drug product	2025-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219500-001	11260038	2040-12-04	U-4279		2025-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219500-001	12329731	2040-12-04	U-4279	Drug product	2025-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219500-001	12558330	2045-05-14	U-4279	Drug product	2026-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219500-001	11123319	2040-12-04		Drug product	2025-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219500-001	11260038	2040-12-04	U-4279		2025-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219500-001	12329731	2040-12-04	U-4279	Drug product	2025-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219500-001	12558330	2045-05-14	U-4279	Drug product	2026-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219500-001	11123319	2040-12-04		Drug product	2025-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219500-001	11260038	2040-12-04	U-4279		2025-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219500-001	12329731	2040-12-04	U-4279	Drug product	2025-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219500-001	11123319	2040-12-04		Drug product	2025-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219500-001	11260038	2040-12-04	U-4279		2025-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219500-001	12329731	2040-12-04	U-4279	Drug product	2025-10-03	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219500-001	11123319	2040-12-04		Drug product	2025-10-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219500-001	11260038	2040-12-04	U-4279		2025-10-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219500-001	12329731	2040-12-04	U-4279	Drug product	2025-10-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219500-001	12558330	2045-05-14	U-4279	Drug product	2026-03-25	`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
Enbumyst	BUMETANIDE	Corstasis USA LLC	d6f752c5-d2bd-4f77-9611-ca2110066d1f	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219500 application number: NDA219500

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
83354	ORIG	2025-09-15