Application 212470

Type: ANDA
Sponsor: JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BUMETANIDE	BUMETANIDE	TABLET;ORAL	0.5MG	No	No
002	BUMETANIDE	BUMETANIDE	TABLET;ORAL	1MG	No	No
003	BUMETANIDE	BUMETANIDE	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212470-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-08-05
A212470-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-08-05
A212470-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-08-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212470-001	AB
A212470-002	AB
A212470-003	AB

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
2026-09-14 22:38:34	2026-08	A212470-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212470-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-08-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212470-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-08-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212470-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212470-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212470-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212470-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212470-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-08-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212470-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212470-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212470-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-08-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212470-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212470-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212470-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-08-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212470-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-08-05	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212470-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2025-08-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212470-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2025-08-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212470-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2025-08-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212470-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212470-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212470-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212470-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212470-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212470-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212470-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212470-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212470-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212470-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212470-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212470-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212470-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212470-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212470-003	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212470-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212470-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212470-003	AB	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 3 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bumetanide	BUMETANIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d4688d53-9baf-4cf0-b37f-47779bce7815	2025-07-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	a7068f36-a863-4af0-9c82-e5394a6e7a54	2025-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Camber Pharmaceuticals, Inc.	084b34ad-36ba-43bd-a43a-1f4b4da26d8f	2025-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Lifestar Pharma LLC	51a344b6-acf9-4ac4-b743-1e63e3df7958	2025-04-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Hikma Pharmaceuticals USA Inc.	b5a68154-8003-4b80-81e2-e926524fb72c	2025-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Qilu Pharmaceutical Co., Ltd.	ef5fe12a-f8ee-4ba7-932b-51bbaccf6575	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
bumetanide	BUMETANIDE	NorthStar Rx, LLC	6b92460e-48ba-44bb-9b61-5e65e5fd82cd	2025-03-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Solco Healthcare LLC	4bcc6cdb-3dfa-4757-bac2-a2dc8bd3a9f6	2025-03-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
BUMETANIDE	BUMETANIDE	HF Acquisition Co LLC, DBA HealthFirst	9bd7a71e-0e78-dae7-e053-2995a90ad110	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUMETANIDE generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	056be255-5880-48e9-b160-bd5b3d82c24a	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	80fe034e-01b7-438e-8378-44fafb7a1d94	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	dfa1f77d-8209-48e9-a6c7-d3b4725a97db	2024-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	American Health Packaging	5e9633e4-151b-4f40-885e-8f364f6f2d18	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	0fb6d547-9966-4352-8974-d02ea58e6445	2024-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Proficient Rx LP	6e3d3ea1-830f-4fc6-9c56-b2ec71875dc6	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Rising Pharma Holdings, Inc	627c9732-eed1-4435-8d79-2e19ab974fd9	2024-06-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
bumetanide	BUMETANIDE	Bryant Ranch Prepack	a60bfe5f-d0d6-4d15-a3de-32dc68e41af3	2024-05-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	f6f12a41-ae6d-4ce6-9bb1-e32679af665f	2024-01-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Amneal Pharmaceuticals NY LLC	9188ab17-8539-48a5-905f-ad35ab5a0b93	2023-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	d85bbced-8a9e-414d-bc88-dd0b68c118df	2023-12-09	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.