Application 018487

Type: NDA
Sponsor: MYLAN

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 43.

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
N018487-001	FUROSEMIDE	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982
N018487-002	FUROSEMIDE	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018487-001	FUROSEMIDE	20MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018487-002	FUROSEMIDE	40MG	TABLET / ORAL	AB	Approved before 1982	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018487-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018487-002	AB	1	`5bbf6a4d5a75…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018487-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018487-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018487-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018487-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018487-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018487-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018487-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018487-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018487-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018487-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018487-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018487-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018487-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018487-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018487-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018487-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018487-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N018487-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018487-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N018487-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018487-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018487-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018487-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N018487-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018487-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N018487-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018487-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N018487-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018487-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N018487-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018487-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N018487-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018487-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N018487-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018487-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018487-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018487-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N018487-002	AB	1	`1c564ffb4f44…`

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 4 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	A-S Medication Solutions	ac64c926-88e9-453a-884c-72ec6a1c746a	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	3f3248cd-d62f-49ca-8788-f059e8facd91	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	c81d313c-65a3-4fb5-b6cd-b1c1ec7dca03	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	5d7eb469-2371-4abb-8f49-be1596f10f27	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	85375079-a9f1-42d4-8e15-c1d31395b29d	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Aphena Pharma Solutions - Tennessee, LLC	3f6529fb-1173-ada3-e063-6294a90a76cb	2025-10-13	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Meitheal Pharmaceuticals Inc.	3aadaca7-3661-4bfe-87f8-6368e4ab6536	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Cardinal Health 107, LLC	d75ba8bd-9494-4306-8443-9c1a90992dd5	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	A-S Medication Solutions	6194face-c26c-46ed-bde7-1e29bfeabd88	2025-10-02	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Lasix	FUROSEMIDE	Validus Pharmaceuticals LLC	2c9b4d8f-0770-482d-a9e6-9c616a440b1a	2025-09-30	Warnings, Adverse reactions	Name fallback generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Bryant Ranch Prepack	53c3f50f-57c6-441b-afea-ec43d7943d1a	2025-09-29	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Coupler LLC	3eed4bbf-7d0e-e852-e063-6394a90a85c2	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	48d8f490-e9d1-4c95-ab2f-414d3f4a9df4	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	c24489c3-65e0-44e3-a50a-8bb0672e8821	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	52e75604-5766-40e8-a13a-8c449e06ebda	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	12137a90-fb35-45d7-8984-0b04793d3e34	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
FUROSEMIDE	FUROSEMIDE	Aurobindo Pharma Limited	a504ee4b-3995-45f2-898c-91116dd81d19	2025-07-19	Warnings, Adverse reactions	Name fallback brand name: FUROSEMIDE generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	PD-Rx Pharmaceuticals, Inc.	3ba730ab-90d4-478a-80b3-1ea3edb03e4d	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	NorthStar Rx LLC	fc3194a3-7e75-4551-8334-4a5cc22d9f8b	2025-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE
Furosemide	FUROSEMIDE	Proficient Rx LP	600ca175-be2b-4c43-b119-133ae21a5601	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Furosemide generic name: FUROSEMIDE

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 · 53 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-0208	Furosemide	furosemide	Mylan Pharmaceuticals Inc.	NDA	Current
0378-0208	Furosemide	furosemide	Mylan Pharmaceuticals Inc.	NDA	Current
0378-0208	Furosemide	furosemide	Mylan Pharmaceuticals Inc.	NDA	Current
0378-0208	Furosemide	furosemide	Mylan Pharmaceuticals Inc.	NDA	Current
0378-0216	Furosemide	furosemide	Mylan Pharmaceuticals Inc.	NDA	Current
0378-0216	Furosemide	furosemide	Mylan Pharmaceuticals Inc.	NDA	Current
0378-0216	Furosemide	furosemide	Mylan Pharmaceuticals Inc.	NDA	Current
0378-0216	Furosemide	furosemide	Mylan Pharmaceuticals Inc.	NDA	Current
43063-806	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-806	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-806	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-806	Furosemide	furosemide	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43353-341	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
50090-2323	Furosemide	furosemide	A-S Medication Solutions	NDA	Current
50090-2560	Furosemide	furosemide	A-S Medication Solutions	NDA	Current
50090-2560	Furosemide	furosemide	A-S Medication Solutions	NDA	Current
51079-072	Furosemide	furosemide	Mylan Institutional Inc.	NDA	Current
51079-072	Furosemide	furosemide	Mylan Institutional Inc.	NDA	Current
51079-072	Furosemide	furosemide	Mylan Institutional Inc.	NDA	Current
51079-072	Furosemide	furosemide	Mylan Institutional Inc.	NDA	Current
51079-073	Furosemide	furosemide	Mylan Institutional Inc.	NDA	Current
51079-073	Furosemide	furosemide	Mylan Institutional Inc.	NDA	Current
51079-073	Furosemide	furosemide	Mylan Institutional Inc.	NDA	Current
51079-073	Furosemide	furosemide	Mylan Institutional Inc.	NDA	Current
53808-0367	Furosemide	FUROSEMIDE	State of Florida DOH Central Pharmacy	NDA	Current
55154-5539	Furosemide	furosemide	Cardinal Health	NDA	Current
55154-5539	Furosemide	furosemide	Cardinal Health 107, LLC	NDA	Current
55154-5539	Furosemide	furosemide	Cardinal Health	NDA	Current
55154-5539	Furosemide	furosemide	Cardinal Health	NDA	Current
55154-5539	Furosemide	furosemide	Cardinal Health	NDA	Current
55154-5540	Furosemide	furosemide	Cardinal Health	NDA	Current
55154-5540	Furosemide	furosemide	Cardinal Health 107, LLC	NDA	Current
55154-5540	Furosemide	furosemide	Cardinal Health	NDA	Current
55154-5540	Furosemide	furosemide	Cardinal Health	NDA	Current
55154-5540	Furosemide	furosemide	Cardinal Health	NDA	Current
63629-8057	Furosemide	furosemide	Bryant Ranch Prepack	NDA	Current
67046-219	Furosemide	furosemide	Contract Pharmacy Services-PA	NDA	Current
67296-0691	Furosemide	furosemide	RedPharm Drug, Inc.	NDA	Current
67296-0691	Furosemide	furosemide	RedPharm Drug, Inc.	NDA	Current
68071-2325	Furosemide	furosemide	NuCare Pharmaceuticals,Inc.	NDA	Current
70518-0120	Furosemide	furosemide	REMEDYREPACK INC.	NDA	Current
70518-0580	Furosemide	furosemide	REMEDYREPACK INC.	NDA	Current
70518-0580	Furosemide	furosemide	REMEDYREPACK INC.	NDA	Current
70518-1072	Furosemide	furosemide	REMEDYREPACK INC.	NDA	Current
70518-1072	Furosemide	furosemide	REMEDYREPACK INC.	NDA	Current
70518-1737	Furosemide	furosemide	REMEDYREPACK INC.	NDA	Current
70518-1737	Furosemide	furosemide	REMEDYREPACK INC.	NDA	Current
71335-0397	Furosemide	furosemide	Bryant Ranch Prepack	NDA	Current
71335-0397	Furosemide	furosemide	Bryant Ranch Prepack	NDA	Current
71335-0601	Furosemide	furosemide	Bryant Ranch Prepack	NDA	Current
71335-0601	Furosemide	furosemide	Bryant Ranch Prepack	NDA	Current
71335-1632	Furosemide	furosemide	Bryant Ranch Prepack	NDA	Current
71610-284	Furosemide	furosemide	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11229	SUPPL	2016-03-14
15019	SUPPL	2016-03-10
934	SUPPL	2010-03-03