Application 203428

Type: ANDA
Sponsor: EMCURE PHARMS LTD

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A203428-001	FUROSEMIDE	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP		2014-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203428-001	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 · 41 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	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203428-001	FUROSEMIDE	10MG/ML	INJECTABLE / INJECTION	AP	2014-08-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A203428-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203428-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203428-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203428-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203428-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203428-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203428-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203428-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203428-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203428-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203428-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203428-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203428-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203428-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203428-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203428-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203428-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203428-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203428-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203428-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203428-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203428-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203428-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203428-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203428-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203428-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203428-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203428-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203428-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203428-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203428-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203428-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203428-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203428-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203428-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203428-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203428-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203428-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203428-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203428-001	AP	1	`cb3db0bc1861…`

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Furosemide	FUROSEMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1b9117d5-0dd9-4577-a1fd-bb0aaf7e68ec	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428 ndc (product): 23155-473
Furosemide	FUROSEMIDE	ProPharma Distribution	38550de1-f099-0cdf-e063-6294a90a9e26	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	ProPharma Distribution	43053bf7-9050-dba8-e063-6294a90a7174	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	NorthStar Rx LLC	fc3194a3-7e75-4551-8334-4a5cc22d9f8b	2025-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	Maiva Pharma Private Limited	e5880bf4-5037-4813-b7cc-656a6832ecb5	2025-06-13	Warnings	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	Avenacy Inc.	7d0db0f7-bf4f-4b0b-9359-2a838626e04b	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	0aab9759-ee48-d1d3-e063-6394a90a2741	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	0a105e0b-b5cc-d929-e063-6294a90a80af	2023-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428
Furosemide	FUROSEMIDE	Medical Purchasing Solutions, LLC	ea4ead7c-c798-2d85-e053-2a95a90ab0b0	2023-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203428 application number: ANDA203428 ndc (product): 71872-7295

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-473	Furosemide	Furosemide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-473	Furosemide	Furosemide	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-473	Furosemide	Furosemide	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-473	Furosemide	Furosemide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-521	Furosemide	Furosemide	Heritage Pharmaceuticals Inc.	ANDA	Current
71872-7295	Furosemide	Furosemide	Medical Purchasing Solutions, LLC	ANDA	Current