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 5 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FUROSEMIDE	FUROSEMIDE	Baxter Healthcare Corporation	c71371a7-75c5-45b8-b762-8d782d4c71bc	2025-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Sagent Pharmaceuticals	d76bd85a-8e57-477e-9607-c9435f1e26fb	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Solco Healthcare LLC	6a0fb397-63ae-4fce-bddf-16a91b1b7a2f	2025-06-18	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Maiva Pharma Private Limited	e5880bf4-5037-4813-b7cc-656a6832ecb5	2025-06-13	Warnings	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Prefferred Pharmaceuticals Inc.	ede9846b-b4c5-4be2-9188-fd65e66cd893	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Coupler LLC	33ec71e2-8fbd-0703-e063-6294a90a62e1	2025-04-29	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Chartwell RX, LLC	8ebd2f10-acfc-48a4-a5db-f20377bda9ce	2025-03-26	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Hikma Pharmaceuticals USA Inc.	ddfc41a9-37d4-49c1-bbf3-969a98cd649c	2025-03-10	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Avenacy Inc.	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Rising Pharma Holdings, Inc.	6101b9b4-f3ef-438e-a857-b4ea55ffc679	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Camber Pharmaceuticals, Inc.	f6221cce-e586-4002-bd14-6ec22eb14e2e	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Ipca Laboratories Limited	0acd293b-ecab-4879-a8e7-cd1b76148f2a	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	809d9734-12dd-3b1f-e053-2a91aa0aadee	2025-01-02	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals,Inc.	813c8e9b-61bc-27c4-e053-2a91aa0a9f45	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Fresenius Kabi USA, LLC	c794c95a-654e-48fe-9596-201fc122ff75	2024-12-09	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Fresenius Kabi USA, LLC	3747bbcd-783d-4baa-bb5b-b6827bf390e3	2024-12-09	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Devatis Inc.	c90bcb14-eb8d-4753-b339-3469c664ecd2	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NCS HealthCare of KY, LLC dba Vangard Labs	114f4f4f-536a-4658-8fd0-2dd8c029b19a	2024-09-17	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	25c0aded-ffcd-4145-a48c-76c5fb220f61	2024-08-23	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	0dd28e18-2e15-45eb-9a61-a9de7bd7d64e	2024-08-23	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.