Application 091258

Type: ANDA
Sponsor: SUN PHARM INDS INC

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
003	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091258-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01
A091258-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01
A091258-003	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01

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 4 · 129 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	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091258-002	FUROSEMIDE	40MG	TABLET / ORAL	2014-04-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091258-003	FUROSEMIDE	80MG	TABLET / ORAL	2014-04-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091258-001	FUROSEMIDE	20MG	TABLET / ORAL	2014-04-01	`301d65b070ca…`

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 3 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Northwind Health Company, LLC	f2b920b2-f8b3-1e6e-e053-2a95a90ae153	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Northwind Health Company, LLC	f3173c0d-2b62-7c7b-e053-2995a90ada05	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Redpharm Drug	3745be12-ea1d-f450-e063-6294a90a148c	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	ProPharma Distribution	38550de1-f099-0cdf-e063-6294a90a9e26	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	54a33042-a163-4f93-96cc-fbd93030e014	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	6864b3f6-c5ad-4588-ad04-5260258c6d8c	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	QPharma Inc	341e29d9-a6f1-4c77-ae44-9b2c423ea6b4	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
LASIX ONYU	FUROSEMIDE	SQ Innovation, Inc.	cb27654f-c7a1-4796-ab08-60a5fa16f5c0	2025-11-14	Warnings, Adverse reactions	Name fallback generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Civica, Inc.	7ecaa5af-d186-4380-b105-e7e528f75cc7	2025-11-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Eugia US LLC	421aa6d5-623b-4dc2-abd5-bb9e7765bf37	2025-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	ProPharma Distribution	43053bf7-9050-dba8-e063-6294a90a7174	2025-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Hikma Pharmaceuticals USA Inc.	9e493331-dddd-496e-abf8-61747fb67aba	2025-11-03	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Civica, Inc.	6d9caaab-d874-4cf1-b9fe-408452a18998	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Henry Schein, Inc.	a9853417-0442-4f53-9543-e0749bc3c80d	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Henry Schein, Inc.	d8407b0e-7838-4ab6-b9dd-1f7ecf1e0a17	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Henry Schein, Inc.	15e4c3a3-7d64-471e-bfdf-6156731e24aa	2025-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC.	4227fab8-a64a-1c9e-e063-6294a90a0682	2025-10-27	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	7842eeab-decf-47e7-9134-0add90549a3d	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	e20257f6-7cfe-43fa-a672-cc1cb312b83a	2025-10-16	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NuCare Pharmaceuticals, Inc.	20eecc36-dfb7-0060-e063-6394a90a9d0b	2025-10-16	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.