Application 209988

Type: NDA
Sponsor: SCPHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSCIX	FUROSEMIDE	INJECTABLE;INJECTION	80MG/10ML	No	No

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
N209988-001	FUROSCIX	FUROSEMIDE	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2022-10-07
N209988-002	FUROSCIX READYFLOW (AUTOINJECTOR)	FUROSEMIDE	80MG/ML (80MG/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2026-07-23

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209988-001	10272064	2034-04-03		Drug product	2022-11-02
N209988-001	11433044	2034-04-03	U-3462		2022-11-02
N209988-001	12370168	2034-04-03	U-3462	Drug product	2025-08-22
N209988-001	9884039	2034-04-03	U-3462		2022-11-02
N209988-002	11497755	2040-01-30		Drug product	2026-08-21
N209988-002	11559535	2040-01-30		Drug product	2026-08-21
N209988-002	11571434	2040-01-30		Drug product	2026-08-21
N209988-002	11998555	2040-01-30	U-4589	Drug product	2026-08-21
N209988-002	12048709	2040-01-30	U-4588	Drug product	2026-08-21
N209988-002	12491193	2040-01-30	U-4588	Drug product	2026-08-21
N209988-002	12491194	2040-01-30	U-4588	Drug product	2026-08-21
N209988-002	12491195	2040-01-30	U-4588	Drug product	2026-08-21
N209988-002	12491196	2040-01-30	U-4588	Drug product	2026-08-21
N209988-002	12491197	2040-01-30	U-4588	Drug product	2026-08-21

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	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	FUROSCIX READYFLOW (AUTOINJECTOR)	80MG/ML (80MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-07-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209988-002	FUROSCIX READYFLOW (AUTOINJECTOR)	80MG/ML (80MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-07-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209988-001	FUROSCIX	80MG/10ML (8MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2022-10-07	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 96 observed states.

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	N209988-001	10272064	2034-04-03		Drug product	2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-001	11433044	2034-04-03	U-3462		2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-001	12370168	2034-04-03	U-3462	Drug product	2025-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-001	9884039	2034-04-03	U-3462		2022-11-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	11497755	2040-01-30		Drug product	2026-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	11559535	2040-01-30		Drug product	2026-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	11571434	2040-01-30		Drug product	2026-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	11998555	2040-01-30	U-4589	Drug product	2026-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	12048709	2040-01-30	U-4588	Drug product	2026-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	12491193	2040-01-30	U-4588	Drug product	2026-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	12491194	2040-01-30	U-4588	Drug product	2026-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	12491195	2040-01-30	U-4588	Drug product	2026-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	12491196	2040-01-30	U-4588	Drug product	2026-08-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209988-002	12491197	2040-01-30	U-4588	Drug product	2026-08-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209988-001	10272064	2034-04-03		Drug product	2022-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209988-001	11433044	2034-04-03	U-3462		2022-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209988-001	12370168	2034-04-03	U-3462	Drug product	2025-08-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209988-001	9884039	2034-04-03	U-3462		2022-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209988-001	10272064	2034-04-03		Drug product	2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209988-001	11433044	2034-04-03	U-3462		2022-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209988-001	12370168	2034-04-03	U-3462	Drug product	2025-08-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209988-001	9884039	2034-04-03	U-3462		2022-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209988-001	10272064	2034-04-03		Drug product	2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209988-001	11433044	2034-04-03	U-3462		2022-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209988-001	12370168	2034-04-03	U-3462	Drug product	2025-08-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209988-001	9884039	2034-04-03	U-3462		2022-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209988-001	10272064	2034-04-03		Drug product	2022-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209988-001	11433044	2034-04-03	U-3462		2022-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209988-001	9884039	2034-04-03	U-3462		2022-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209988-001	10272064	2034-04-03		Drug product	2022-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209988-001	11433044	2034-04-03	U-3462		2022-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209988-001	9884039	2034-04-03	U-3462		2022-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209988-001	10272064	2034-04-03		Drug product	2022-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209988-001	11433044	2034-04-03	U-3462		2022-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209988-001	9884039	2034-04-03	U-3462		2022-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209988-001	10272064	2034-04-03		Drug product	2022-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209988-001	11433044	2034-04-03	U-3462		2022-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209988-001	9884039	2034-04-03	U-3462		2022-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209988-001	10272064	2034-04-03		Drug product	2022-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209988-001	11433044	2034-04-03	U-3462		2022-11-02	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209988-001	NP	2025-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209988-001	NP	2025-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209988-001	NP	2025-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209988-001	NP	2025-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209988-001	NP	2025-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209988-001	NP	2025-10-07	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209988-001	NP	2025-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209988-001	NP	2025-10-07	`d06236e962d9…`

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
FUROSCIX	FUROSEMIDE INJECTION 80 MG/ 10 ML	scPharmaceuticals Inc., a wholly owned subsidiary of MannKind Corporation	eac958dd-8d43-e44e-e053-2995a90a4d5e	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209988 application number: NDA209988 ndc (product): 71767-100

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71767-100	Furoscix	furosemide injection 80 mg/ 10 mL	scPharmaceuticals Inc.	NDA	Current
71767-100	FUROSCIX	furosemide injection 80 mg/ 10 mL	scPharmaceuticals Inc.	NDA	Current
71767-100	FUROSCIX	furosemide injection 80 mg/ 10 mL	scPharmaceuticals, Inc.	NDA	Current
71767-100	FUROSCIX	furosemide injection 80 mg/ 10 mL	scPharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84653	SUPPL	2026-01-06
84539	SUPPL	2025-12-23
81518	SUPPL	2025-03-11
81476	SUPPL	2025-03-07
79373	SUPPL	2024-08-12
79369	SUPPL	2024-08-12
77097	ORIG	2023-12-21
72999	ORIG	2022-12-22
72308	ORIG	2022-10-11
72291	ORIG	2022-10-11