Application 018753

Type: NDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	20MG	No	No
002	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	40MG	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
N018753-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL			1984-02-28
N018753-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL			1984-02-28

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018753-001	FUROSEMIDE	20MG	TABLET / ORAL	1984-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018753-002	FUROSEMIDE	40MG	TABLET / ORAL	1984-02-28	`74a2ff9319b5…`

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 6 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	809b4f68-4fca-c201-e053-2a91aa0ac18e	2024-07-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Accord Healthcare, Inc.	f6f64972-714c-4ee9-8a5e-9ffcab41a73b	2024-07-11	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	307c3b89-f37f-45ee-8ec7-d402008cf2fa	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Precision Dose Inc.	3fd02fb5-98a0-4eda-a0ec-41faabe04706	2024-06-13	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	6cbf3834-0433-4dc0-e053-2a91aa0a8f8a	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	7316929d-413a-e78f-e053-2a91aa0a417e	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	73e5c8f3-32f8-114c-e053-2a91aa0ab500	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	4b3e2e13-a657-4da5-b536-8ae0a26812e0	2024-06-03	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	83662449-f2b1-48a3-9021-13037e64e6ea	2024-04-23	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Calvin Scott & Co., Inc.	b2cc89e5-6619-4113-ad31-48076652c856	2024-04-18	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	3b028a3c-102a-40f1-820e-b187ff1e1803	2024-03-22	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	d07ff11c-c1ab-41e6-a455-f2b89340106e	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	a5e94bf3-bb18-4c81-98af-8c1cb7e00496	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	75d68f19-424c-109e-e053-2991aa0ac857	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	c5db4434-0b47-038c-e053-2995a90ad7fe	2024-01-28	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	c5db2be1-088f-1110-e053-2a95a90acac8	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	7b9af6a4-e1da-eb95-e053-2991aa0a031d	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	0aab9759-ee48-d1d3-e063-6394a90a2741	2024-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	DIRECT RX	9ec7808e-9201-4b8c-9790-d329320dc6c4	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	6c2ee3a4-afea-4e1f-84e6-def0221ad437	2024-01-02	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.