Application 217153

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUMETANIDE	BUMETANIDE	INJECTABLE;INJECTION	0.25MG/ML	No	No

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

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
A217153-001	BUMETANIDE	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP		2024-09-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217153-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217153-001	BUMETANIDE	0.25MG/ML	INJECTABLE / INJECTION	AP	2024-09-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A217153-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A217153-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217153-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217153-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217153-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217153-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217153-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217153-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217153-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217153-001	AP	1	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217153-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217153-001	AP	1	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217153-001	AP	1	`a50c72e98297…`

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 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	REMEDYREPACK INC.	de008936-e8a3-4e65-bb6a-d925b68a5f50	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	REMEDYREPACK INC.	0fb78afc-d8bc-4ae8-8c0a-6d9c6f7a22c5	2026-09-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Enbumyst	BUMETANIDE	Corstasis USA LLC	d6f752c5-d2bd-4f77-9611-ca2110066d1f	2026-08-27	Warnings, Adverse reactions	Name fallback generic name: BUMETANIDE
Bumetanide	BUMETANIDE	NorthStar Rx LLC	551918e1-96c4-453a-870c-61b282882206	2026-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Major Pharmaceuticals	a29cf117-00d0-4948-b646-013c8791ea39	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Sagent Pharmaceuticals	c38a404d-a919-4a2c-9fbb-d0655dee9516	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Civica, Inc.	4a9229c8-89ba-423e-8e36-f56bc329ed38	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Hikma Pharmaceuticals USA Inc.	681b5e9d-e2c7-4f29-aaad-e06d4a528c11	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Anthea Pharma Private Limited	9058fc52-f3f6-4d7f-b2a0-b1e2c714b133	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Cardinal Health 107, LLC	e7c3c63e-3aea-4b33-b165-7c7449359674	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Sandoz Inc	8914d8bf-61b7-4cd2-a8ef-7e1c5df37828	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	a4dd156d-0f17-43d9-bf78-2d358c50681b	2026-05-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	43ab2dd6-39ba-4a53-aa84-d7975038ef43	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	37179b2d-6589-40d8-8121-7561a6791d38	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Cardinal Health 107, LLC	0a5577f5-d2fe-4b0d-8245-78ee77df30fd	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Cardinal Health 107, LLC	9bd4fcd3-3020-41f2-b112-023b5db4487d	2026-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Cardinal Health 107, LLC	68f18d36-ffc2-4481-9286-914cfcf573a0	2026-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Proficient Rx LP	51d5f639-5d25-4ada-8bbe-ada2386173bf	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Proficient Rx LP	ae7dd557-f7a1-4d5a-b80e-3ca3a6e4943b	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Sun Pharmaceutical Industries, Inc.	5c753aae-77b7-4add-8453-385a8f62d7db	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE

Reported adverse events (FAERS/openFDA)#

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