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 1 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	dba00759-87b4-4ecf-998e-ba03ed3d2f1a	2026-08-17	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Redpharm Drug	58d2a38d-75f8-dcb9-e063-6294a90a10d7	2026-08-12	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	58cc1e38-6000-1489-e063-6394a90a5978	2026-08-11	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
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	Name fallback generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	7cdcd001-ab4b-4210-a455-2e17a7bc4972	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	3d312ab0-589c-427b-84da-18887244bfc9	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	St. Mary's Medical Park Pharmacy	febeaf8c-0f4b-cc40-e053-6394a90a873e	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	916de29e-228c-4dfc-bcee-ad9a641316bd	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	REMEDYREPACK INC.	e8c27f1c-dc81-44b1-8663-a7d663bad89f	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Atlantic Biologicals Corp.	54ed0dd9-2fa8-269a-e063-6294a90a607c	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	75d5611a-f9e0-1841-e053-2991aa0af415	2026-06-23	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Unit Dose Solutions, Inc.	54dd664a-c7ec-27f3-e063-6294a90aff9f	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	2a5bcf50-6d63-463a-915e-a72ea2e5f131	2026-06-18	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Granulation Technology, Inc.	462e8917-cbe0-f4f9-e063-6394a90ab4ff	2026-06-17	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Atlantic Biologicals Corps	9c342198-7162-4cc5-bda1-bc4054a4292b	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Coupler LLC	53e58232-f7f9-c09b-e063-6394a90a5bc4	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	42478c55-9056-487a-89a9-d36904beea12	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Major Pharmaceuticals	6be1addd-a811-47fc-8650-6870d661c234	2026-05-26	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	71b48f4d-9936-448c-9e3a-33f1182e1039	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Hospira, Inc.	39fd32f2-6bb7-4a65-d298-e48d26bc80c7	2026-05-13	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.