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 7 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	A-S Medication Solutions	60cf5e60-9a7a-42c2-95b5-016f7a68ffc4	2023-12-18	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	0a105e0b-b5cc-d929-e063-6294a90a80af	2023-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	a2e46e16-4adf-4599-b69d-a6f6f891ba75	2023-10-31	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	020bc039-9e99-4895-96f8-0c6a556d3e67	2023-10-04	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Medical Purchasing Solutions, LLC	6a2235e8-d488-2d43-e053-2991aa0aa485	2023-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Medical Purchasing Solutions, LLC	6947af02-f50b-7f9c-e053-2a91aa0a45cd	2023-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	bbf03f9a-ae33-8da1-e053-2a95a90a3bdb	2023-05-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	d8a064cc-c741-8b80-e053-2a95a90a364c	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	ea4ead7c-c798-2d85-e053-2a95a90ab0b0	2023-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	25171259-dcf1-4984-9581-cd69dee8dffb	2023-04-19	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Calvin Scott & Co., Inc.	43be0231-0d88-4a21-b2ab-793155cbddb2	2023-03-23	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	01a5f094-b473-4e46-9e61-69d5ec6dd766	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	6820724c-1ca5-451c-9d2b-2d38e60036f5	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	440aaaed-47df-4bb5-8b41-2c8056893679	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	15ae6f44-88dd-4455-b1f7-4718c91e7b66	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	3ad12e70-3c2e-44af-bb6b-5762d181c76b	2023-03-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	52f0c9d5-396f-4033-abe8-145eec3e6983	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Lifestar Pharma LLC	92f3ab5d-361c-4e12-bb50-fd4a9f195a8f	2022-12-22	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Proficient Rx LP	595ddaf2-c2cb-44a4-a46c-53bcfe6bd752	2022-12-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Sagent Pharmaceuticals	d63c1277-dd7e-4d21-9e80-68143f55e2dc	2022-11-29	Boxed warning, 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.