Application 018868

Type: NDA
Sponsor: KALAPHARM

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
N018868-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL			1983-06-28
N018868-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL			1983-06-28

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	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018868-001	FUROSEMIDE	20MG	TABLET / ORAL	1983-06-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018868-002	FUROSEMIDE	40MG	TABLET / ORAL	1983-06-28	`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 2 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FUROSEMIDE	FUROSEMIDE	Hospira, Inc.	aaced7a8-c3d7-4d66-8c07-aa407b8b3f35	2026-05-13	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	8e0bac29-5a8b-4d4e-93b3-2e21eb3b0650	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Preferred Pharmaceuticals, Inc.	a23fc1e0-2d16-43a8-a34e-f6505dcd6316	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Preferred Pharmaceuticals Inc.	cad102d7-0197-4cff-bb80-9f0b5bcb599b	2026-04-29	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	7181e528-c862-4dd7-8446-9011e4c7312a	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Redpharm Drug	37457273-38a1-f938-e063-6294a90a50ab	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1b9117d5-0dd9-4577-a1fd-bb0aaf7e68ec	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Coupler LLC	4cc2c2d1-2fa4-f6b6-e063-6294a90a290e	2026-03-11	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Direct_Rx	e9be5c3b-4b18-7ad2-e053-2995a90a4a8b	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Marlex Pharmaceuticals, Inc.	4bd1b15e-354e-051f-e063-6294a90a3f3b	2026-03-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	bd45c963-a413-e9a1-e053-2a95a90a1438	2026-02-19	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Preferred Pharmaceuticals Inc.	adda78ee-0cf5-4613-a748-5d6571afe354	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Cardinal Health 107, LLC	2590ebb6-ce2a-4e23-9244-e54e3010d488	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	AvKARE	d4c532be-1f3f-60d3-e053-2995a90a98be	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Meitheal Pharmaceuticals Inc.	a2e3c748-28ce-4c50-a182-721912919840	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	8f56d6f6-a5ea-4171-9e24-d2fdb11a65f8	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Micro Labs Limited	2f547f7c-0322-465c-9764-43f955d98ab2	2026-01-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Phlow Corporation	08a44bdd-028d-41af-9d4e-70971b0bcc4e	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Northwind Health Company, LLC	13ba97a7-598a-76a4-e063-6294a90a45c5	2026-01-02	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Northwind Health Company, LLC	1d99e151-75ba-6a75-e063-6294a90a4360	2026-01-01	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.