Application 018579

Type: NDA
Sponsor: AM REGENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	INJECTABLE;INJECTION	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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
N018579-001	FUROSEMIDE	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	1983-11-30

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.

Product history page 1 of 2 · 43 observed 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	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018579-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	RLD	1983-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018579-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	RLD	1983-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018579-001	FUROSEMIDE	10MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD	1983-11-30	`f41ea6bd6efb…`

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 4 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	A-S Medication Solutions	ac64c926-88e9-453a-884c-72ec6a1c746a	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	3f3248cd-d62f-49ca-8788-f059e8facd91	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	c81d313c-65a3-4fb5-b6cd-b1c1ec7dca03	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	5d7eb469-2371-4abb-8f49-be1596f10f27	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	85375079-a9f1-42d4-8e15-c1d31395b29d	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	3f6529fb-1173-ada3-e063-6294a90a76cb	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Meitheal Pharmaceuticals Inc.	3aadaca7-3661-4bfe-87f8-6368e4ab6536	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	d75ba8bd-9494-4306-8443-9c1a90992dd5	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	6194face-c26c-46ed-bde7-1e29bfeabd88	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Lasix	FUROSEMIDE	Validus Pharmaceuticals LLC	2c9b4d8f-0770-482d-a9e6-9c616a440b1a	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	53c3f50f-57c6-441b-afea-ec43d7943d1a	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Coupler LLC	3eed4bbf-7d0e-e852-e063-6394a90a85c2	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	48d8f490-e9d1-4c95-ab2f-414d3f4a9df4	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	c24489c3-65e0-44e3-a50a-8bb0672e8821	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	52e75604-5766-40e8-a13a-8c449e06ebda	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	12137a90-fb35-45d7-8984-0b04793d3e34	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Aurobindo Pharma Limited	a504ee4b-3995-45f2-898c-91116dd81d19	2025-07-19	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	3ba730ab-90d4-478a-80b3-1ea3edb03e4d	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NorthStar Rx LLC	fc3194a3-7e75-4551-8334-4a5cc22d9f8b	2025-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Proficient Rx LP	600ca175-be2b-4c43-b119-133ae21a5601	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-721	furosemide	furosemide	Rebel Distributors Corp	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79813	SUPPL	2024-10-03
79806	SUPPL	2024-10-03
71017	SUPPL	2022-05-06
70999	SUPPL	2022-05-05
11240	SUPPL	2011-08-16