Application 018902

Type: NDA
Sponsor: FRESENIUS KABI USA

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
N018902-001	FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP		1984-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018902-001	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.

Product history page 1 of 2 · 42 observed 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	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018902-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	1984-05-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018902-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018902-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018902-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018902-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018902-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018902-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018902-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018902-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018902-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018902-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018902-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018902-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018902-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018902-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018902-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018902-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018902-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018902-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018902-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018902-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018902-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018902-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018902-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018902-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018902-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018902-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018902-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018902-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018902-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018902-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018902-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018902-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018902-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018902-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018902-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018902-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018902-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018902-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018902-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018902-001	AP	1	`e64feba35796…`

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 1 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	42478c55-9056-487a-89a9-d36904beea12	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018902 application number: NDA018902 ndc (product): 55154-9581
Furosemide	FUROSEMIDE	Phlow Corporation	08a44bdd-028d-41af-9d4e-70971b0bcc4e	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018902 application number: NDA018902 ndc (product): 81565-201
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	d75ba8bd-9494-4306-8443-9c1a90992dd5	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018902 application number: NDA018902 ndc (product): 55154-9582
Furosemide	FUROSEMIDE	Fresenius Kabi USA, LLC	c794c95a-654e-48fe-9596-201fc122ff75	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018902 application number: NDA018902 ndc (product): 63323-280
Furosemide	FUROSEMIDE	Fresenius Kabi USA, LLC	3747bbcd-783d-4baa-bb5b-b6827bf390e3	2024-12-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018902 application number: NDA018902 ndc (product): 63323-280
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	c5db4434-0b47-038c-e053-2995a90ad7fe	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018902 application number: NDA018902 ndc (product): 51662-1574
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	c5db2be1-088f-1110-e053-2a95a90acac8	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018902 application number: NDA018902 ndc (product): 51662-1572
FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	c5d9b063-e3fe-ec2f-e053-2995a90ab3f2	2021-06-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018902 application number: NDA018902 ndc (product): 51662-1575

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51662-1572	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1572	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1574	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1574	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1574	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1574	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
51662-1575	FUROSEMIDE	FUROSEMIDE	HF Acquisition Co LLC, DBA HealthFirst	NDA	Current
55154-9581	Furosemide	FUROSEMIDE	Cardinal Health	NDA	Current
55154-9581	Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	NDA	Current
55154-9582	Furosemide	FUROSEMIDE	Cardinal Health	NDA	Current
55154-9582	Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	NDA	Current
63323-280	Furosemide	FUROSEMIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-280	Furosemide	FUROSEMIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-280	Furosemide	FUROSEMIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-280	Furosemide	FUROSEMIDE	Fresenius Kabi USA, LLC	NDA	Current
63323-280	Furosemide	FUROSEMIDE	Fresenius Kabi USA, LLC	NDA	Current
81565-201	Furosemide	FUROSEMIDE	Phlow Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79815	SUPPL	2024-10-03
79808	SUPPL	2024-10-03
73606	SUPPL	2023-02-24
73602	SUPPL	2023-02-24
70766	SUPPL	2022-04-14
70757	SUPPL	2022-04-13
45353	SUPPL	2016-09-21
33640	SUPPL	2016-03-14
16087	SUPPL	2016-03-10