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 8 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Leading Pharma, LLC	b5c6fcf4-fd37-4fee-8dac-1a3273d95ffe	2022-11-11	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Precision Dose Inc.	4a746634-379b-4847-a965-7607d2a71bed	2022-09-21	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	6f124d7d-a19d-4de6-8ea4-719a42eb520b	2022-03-10	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	c5d9b063-e3fe-ec2f-e053-2995a90ab3f2	2021-06-28	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Proficient Rx LP	ce84359c-2f76-421a-9b2b-79b1c2be2f20	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Gland Pharma Limited	644704c0-e6a5-4804-bfa6-795c8f83aa7a	2020-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	1d2733ac-6fa6-44d1-96d4-f1a698045ad2	2018-04-18	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	6fbf7f3d-7566-44d5-9507-c4460238fc91	2018-02-09	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.