Application 217294

Type: NDA
Sponsor: SQ INNOVATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LASIX ONYU	FUROSEMIDE	SOLUTION;SUBCUTANEOUS	80MG/2.67ML (30MG/ML)	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
N217294-001	LASIX ONYU	FUROSEMIDE	80MG/2.67ML (30MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2025-10-07

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217294-001	11246851	2040-01-03	U-4576	Drug product	2026-07-22
N217294-001	12318363	2040-01-03		Drug product	2026-07-22
N217294-001	12403120	2042-01-10	U-4576	Drug product	2026-07-22

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	N217294-001	LASIX ONYU	80MG/2.67ML (30MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217294-001	LASIX ONYU	80MG/2.67ML (30MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217294-001	LASIX ONYU	80MG/2.67ML (30MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217294-001	LASIX ONYU	80MG/2.67ML (30MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-10-07	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217294-001	LASIX ONYU	80MG/2.67ML (30MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-10-07	`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	N217294-001	11246851	2040-01-03	U-4576	Drug product	2026-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217294-001	12318363	2040-01-03		Drug product	2026-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217294-001	12403120	2042-01-10	U-4576	Drug product	2026-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217294-001	11246851	2040-01-03	U-4576	Drug product	2026-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217294-001	12318363	2040-01-03		Drug product	2026-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217294-001	12403120	2042-01-10	U-4576	Drug product	2026-07-22	`caaa826d4ba7…`

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
LASIX ONYU	FUROSEMIDE	SQ Innovation, Inc.	cb27654f-c7a1-4796-ab08-60a5fa16f5c0	2025-11-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217294 application number: NDA217294

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
83716	ORIG	2025-10-10
83691	ORIG	2025-10-08