Application 208435

Type: ANDA
Sponsor: AREVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	INJECTABLE;INJECTION	10MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208435-001	FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP		2020-12-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A208435-001	AP

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208435-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2020-12-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208435-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208435-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208435-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208435-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208435-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208435-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208435-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208435-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208435-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208435-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208435-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208435-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208435-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208435-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208435-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208435-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208435-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208435-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208435-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208435-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208435-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208435-001	AP	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208435-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208435-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208435-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208435-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208435-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208435-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208435-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208435-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208435-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208435-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208435-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208435-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208435-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208435-001	AP	1	`a50c72e98297…`

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 · 152 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	REMEDYREPACK INC.	571a52ed-5258-46d5-a0d2-9a984cf73895	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