Application 018823

Type: NDA
Sponsor: HIKMA

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 1.

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
N018823-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB		1983-11-10
N018823-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB		1983-11-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N018823-001	AB
N018823-002	AB

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 · 82 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
2026-02-19 14:30 UTC	2026-02	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018823-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018823-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-10	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N018823-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018823-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018823-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018823-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018823-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018823-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018823-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018823-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018823-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018823-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018823-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018823-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018823-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018823-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018823-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018823-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018823-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018823-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018823-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018823-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018823-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018823-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018823-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018823-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018823-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018823-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018823-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018823-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018823-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018823-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018823-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018823-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018823-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018823-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018823-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018823-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018823-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018823-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018823-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018823-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Northwind Health Company, LLC	f3173c0d-2b62-7c7b-e053-2995a90ada05	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018823 application number: NDA018823
Furosemide	FUROSEMIDE	Hikma Pharmaceuticals USA Inc.	9e493331-dddd-496e-abf8-61747fb67aba	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018823 application number: NDA018823 ndc (product): 0054-8297 ndc (product): 0054-4299 ndc (product): 0054-8299 ndc (product): 0054-4297
Furosemide	FUROSEMIDE	A-S Medication Solutions	a2e46e16-4adf-4599-b69d-a6f6f891ba75	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018823 application number: NDA018823 ndc (product): 50090-6219
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	6fbf7f3d-7566-44d5-9507-c4460238fc91	2018-02-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018823 application number: NDA018823 ndc (product): 43353-069 ndc (product): 43353-747

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-4297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-4299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8297	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0054-8299	Furosemide	Furosemide	West-Ward Pharmaceuticals Corp.	NDA	Current
0615-7937	Furosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-7937	Furosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-7938	Fuosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-7938	Fuosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
43353-069	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-747	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50090-2951	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-2951	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-2951	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-3262	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-3262	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-4109	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-4111	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-4111	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-6219	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-6221	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
51407-113	Furosemide	Furosemide	Golden State Medical Supply Inc.	NDA	Current
51407-113	Furosemide	Furosemide	Golden State Medical Supply Inc.	NDA	Current
51407-113	Furosemide	Furosemide	Golden State Medical Supply	NDA	Current
51407-113	Furosemide	Furosemide	Golden State Medical Supply, Inc.	NDA	Current
51407-114	Furosemide	Furosemide	Golden State Medical Supply Inc.	NDA	Current
51407-114	Furosemide	Furosemide	Golden State Medical Supply Inc.	NDA	Current
51407-114	Furosemide	Furosemide	Golden State Medical Supply	NDA	Current
51407-114	Furosemide	Furosemide	Golden State Medical Supply, Inc.	NDA	Current
68788-1966	Furosemide	Furosemide	Preferred Pharmaceuticals, Inc.	NDA	Current
70518-0809	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0809	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0809	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0809	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0836	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0836	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0836	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0836	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70934-412	Furosemide	Furosemide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
70934-412	Furosemide	Furosemide	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	NDA	Current
70934-412	Furosemide	Furosemide	Denton Pharma, Inc. dba Northwind Pharmaceuticals	NDA	Current
70934-737	Furosemide	Furosemide	Denton Pharma, Inc. dba Northwind Pharmaceuticals	NDA	Current
71610-308	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
71610-309	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
49011	SUPPL	2017-07-18
49004	SUPPL	2017-07-17