Application 018413

Type: NDA
Sponsor: AVET

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
N018413-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL			1983-11-30
N018413-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL			1983-11-30

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	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	1983-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	1983-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018413-001	FUROSEMIDE	20MG	TABLET / ORAL		1983-11-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018413-002	FUROSEMIDE	40MG	TABLET / ORAL		1983-11-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N018413-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018413-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N018413-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018413-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018413-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018413-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018413-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018413-002	AB	1	`ea99ee380514…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Chartwell RX, LLC	8ebd2f10-acfc-48a4-a5db-f20377bda9ce	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018413 application number: NDA018413

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-0446	Furosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
0615-1569	Furosemide	Furosemide	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
66116-419	Furosemide	Furosemide	MedVantx, Inc.	ANDA	Current
67046-221	Furosemide	Furosemide	Contract Pharmacy Services-PA	ANDA	Current