Application 018569

Type: NDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	40MG	No	No
002	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	20MG	No	No
005	FUROSEMIDE	FUROSEMIDE	TABLET;ORAL	80MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	RLD / RS	Approval date
N018569-001	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982
N018569-002	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982
N018569-005	FUROSEMIDE	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N018569-001	AB
N018569-002	AB
N018569-005	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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018569-001	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018569-002	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018569-005	FUROSEMIDE	80MG	TABLET / ORAL	AB		1984-08-14	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N018569-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018569-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N018569-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N018569-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018569-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018569-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018569-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018569-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018569-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018569-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018569-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018569-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018569-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018569-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018569-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018569-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018569-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018569-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018569-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018569-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018569-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018569-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018569-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018569-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018569-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018569-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018569-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018569-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018569-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018569-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018569-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018569-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018569-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018569-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018569-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018569-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018569-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018569-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018569-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018569-001	AB	1	`79d66fd596c7…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Granulation Technology, Inc.	462e8917-cbe0-f4f9-e063-6394a90ab4ff	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018569 application number: NDA018569
Furosemide	FUROSEMIDE	Marlex Pharmaceuticals, Inc.	4bd1b15e-354e-051f-e063-6294a90a3f3b	2026-03-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018569 application number: NDA018569

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1571	Furosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0781-1446	Furosemide	Furosemide	Sandoz Inc	NDA	Current
0781-1446	Furosemide	Furosemide	Sandoz Inc	NDA	Current
0781-1818	Furosemide	Furosemide	Sandoz Inc	NDA	Current
0781-1818	Furosemide	Furosemide	Sandoz Inc	NDA	Current
0781-1966	Furosemide	Furosemide	Sandoz Inc	NDA	Current
0781-1966	Furosemide	Furosemide	Sandoz Inc	NDA	Current
43353-737	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
48433-314	Furosemide	Furosemide	Safecor Health, LLC	NDA	Current
49999-030	Furosemide	Furosemide	Lake Erie Medical DBA Quality Care Products LLC	NDA	Current
50090-0150	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
50090-0154	Furosemide	Furosemide	A-S Medication Solutions	NDA	Current
55154-5875	Furosemide	Furosemide	Cardinal Health	NDA	Current
67046-222	Furosemide	Furosemide	Contract Pharmacy Services-PA	NDA	Current
67544-075	Furosemide	Furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
68071-3144	Furosemide	Furosemide	NuCare Pharmaceuticals, Inc.	NDA	Current
68071-4015	Furosemide	Furosemide	NuCare Pharmaceuticals,Inc.	NDA	Current
70518-0584	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0584	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0745	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70518-0745	Furosemide	Furosemide	REMEDYREPACK INC.	NDA	Current
70859-020	Furosemide	Furosemide	NuCare Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65748	SUPPL	2020-12-28
65698	SUPPL	2020-12-23
45529	SUPPL	2016-10-12