Application 202747

Type: ANDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FUROSEMIDE	FUROSEMIDE	INJECTABLE;INJECTION	10MG/ML	No	Yes

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
A202747-001	FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202747-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202747-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	RS	2014-01-27	`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	A202747-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202747-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202747-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202747-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202747-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202747-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202747-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202747-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202747-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202747-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202747-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202747-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202747-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202747-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202747-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202747-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202747-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202747-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202747-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202747-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202747-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202747-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202747-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202747-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202747-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202747-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202747-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202747-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202747-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202747-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202747-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202747-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202747-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202747-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202747-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202747-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202747-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202747-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202747-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202747-001	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	2590ebb6-ce2a-4e23-9244-e54e3010d488	2026-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202747 application number: ANDA202747 ndc (product): 55154-4452
FUROSEMIDE	FUROSEMIDE	Civica, Inc.	7ecaa5af-d186-4380-b105-e7e528f75cc7	2025-11-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202747 application number: ANDA202747 ndc (product): 72572-190
FUROSEMIDE	FUROSEMIDE	Henry Schein, Inc.	a9853417-0442-4f53-9543-e0749bc3c80d	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202747 application number: ANDA202747 ndc (product): 0404-9862
Furosemide	FUROSEMIDE	Henry Schein, Inc.	d8407b0e-7838-4ab6-b9dd-1f7ecf1e0a17	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202747 application number: ANDA202747 ndc (product): 0404-9863
FUROSEMIDE	FUROSEMIDE	REMEDYREPACK INC.	ab1a7e16-f746-41af-8faf-b69d3ffd62ba	2025-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202747 application number: ANDA202747
FUROSEMIDE	FUROSEMIDE	Baxter Healthcare Corporation	c71371a7-75c5-45b8-b762-8d782d4c71bc	2025-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202747 application number: ANDA202747 ndc (product): 36000-282 ndc (product): 36000-063 ndc (product): 36000-064 ndc (product): 36000-284 ndc (product): 36000-065 ndc (product): 36000-283
FUROSEMIDE	FUROSEMIDE	Medical Purchasing Solutions, LLC	6a2235e8-d488-2d43-e053-2991aa0aa485	2023-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202747 application number: ANDA202747 ndc (product): 71872-7059
FUROSEMIDE	FUROSEMIDE	Medical Purchasing Solutions, LLC	6947af02-f50b-7f9c-e053-2a91aa0a45cd	2023-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202747 application number: ANDA202747 ndc (product): 71872-7127

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
0404-9862	FUROSEMIDE	furosemide	Henry Schein, Inc.	ANDA	Current
0404-9862	FUROSEMIDE	furosemide	Henry Schein, Inc.	ANDA	Current
0404-9863	Furosemide	Furosemide	Henry Schein, Inc.	ANDA	Current
0404-9863	Furosemide	Furosemide	Henry Schein, Inc.	ANDA	Current
36000-063	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-063	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-063	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-063	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-063	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-064	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-064	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-064	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-064	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-064	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-065	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-065	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-065	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-065	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-065	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-282	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-282	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-282	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-282	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-282	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-283	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-283	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-283	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-283	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-283	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-284	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-284	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-284	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-284	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
36000-284	FUROSEMIDE	furosemide	Baxter Healthcare Corporation	ANDA	Current
52584-091	Furosemide	Furosemide	General Injectables and Vaccines, Inc.	ANDA	Current
52584-091	Furosemide	Furosemide	General Injectables and Vaccines, Inc.	ANDA	Current
52584-283	Furosemide	Furosemide	General Injectables and Vaccines, Inc.	ANDA	Current
52584-283	Furosemide	Furosemide	General Injectables and Vaccines, Inc.	ANDA	Current
52584-283	Furosemide	Furosemide	General Injectables and Vaccines, Inc.	ANDA	Current
52584-283	Furosemide	Furosemide	General Injectables and Vaccines, Inc.	ANDA	Current
52584-284	FUROSEMIDE	furosemide	General Injectables & Vaccines, Inc.	ANDA	Current
52584-284	FUROSEMIDE	furosemide	General Injectables & Vaccines, Inc.	ANDA	Current
52584-284	FUROSEMIDE	furosemide	General Injectables & Vaccines, Inc.	ANDA	Current
55154-4452	FUROSEMIDE	furosemide	Cardinal Health	ANDA	Current
55154-4452	FUROSEMIDE	furosemide	Cardinal Health	ANDA	Current
55154-4452	FUROSEMIDE	furosemide	Cardinal Health 107, LLC	ANDA	Current
71872-7059	FUROSEMIDE	furosemide	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7059	FUROSEMIDE	furosemide	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7127	FUROSEMIDE	furosemide	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7127	FUROSEMIDE	furosemide	Medical Purchasing Solutions, LLC	ANDA	Current
72572-190	FUROSEMIDE	furosemide	Civica, Inc.	ANDA	Current