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 4 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bumetanide	BUMETANIDE	Zydus Pharmaceuticals (USA) Inc.	525138cd-832a-41d0-84b0-83921b12bd2a	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bumetanide generic name: BUMETANIDE
bumetanide	BUMETANIDE	Zydus Lifesciences Limited	82eb62ca-c32b-4ff8-9f71-43219b240480	2023-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bumetanide generic name: BUMETANIDE
bumetanide	BUMETANIDE	A-S Medication Solutions	cf29e436-b630-4b03-bb9b-9267ae77dc00	2023-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Sandoz Inc	05cb961d-ac33-4bcf-b04e-411e496c43c1	2023-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Civica, Inc.	308c690f-c2bd-4c32-8728-42ec95425f77	2023-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	7f9dccf8-37ff-454b-9d55-7f1d631c8483	2023-01-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	GLENMARK PHARMACEUTICALS INC., USA	680563fe-5d3a-49bc-86a5-740bda2acebe	2023-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	f6ff0d37-c67d-4b9f-8b62-5deda9783c28	2023-01-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	8bed63fb-91ec-4132-ac0a-16c4c6f58d95	2023-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Fresenius Kabi USA, LLC	a007f3aa-3977-4be3-a9a2-db3d458bca58	2022-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Novadoz Pharmaceuticals LLC	387edfd4-be85-41cd-8a6d-14e6a022b5a9	2022-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Gland Pharma Limited	4d1ed6b2-c410-4f52-9b8a-aa256c37089e	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Aphena Pharma Solutions - Tennessee, LLC	7e47e7b1-d28a-4e12-882f-cf193b7f2697	2019-09-30	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.