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 2 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	AvPAK	87385a0a-e7e6-8b7f-e053-2991aa0aa21a	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Mullan Pharmaceutical Inc.	b7cd724b-817b-4b45-8133-1ebf505867e7	2026-03-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	First Nation Group, LLC	79b77945-74a7-4cb5-8aa0-33a7babdf6d9	2026-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	c8e243c0-805a-4d81-bec9-f5be6eb9f2bc	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Novadoz Pharmaceuticals LLC	cddd33fb-25b0-49ca-ab32-7c79a9b3a384	2026-02-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	b338ae20-fc07-4ec5-9e68-be636f75ce1a	2026-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	f4326e53-5217-48d4-a089-1184442049ac	2026-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
bumetanide	BUMETANIDE	A-S Medication Solutions	8b5a38cc-1e76-4821-b286-31bad3bd6913	2026-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Exelan Pharmaceuticals, Inc.	06745425-e7e7-4413-b9ff-22b121f0ea9a	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	NCS HealthCare of KY, LLC dba Vangard Labs	fa4e5faf-c91a-457b-bd2b-14a9add51ac8	2026-01-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	e3d38c1d-9b35-478e-bc2f-3e82b09a1538	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Advagen Pharma Limited	94078edd-b9c0-449e-baaf-a9afceccb407	2026-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Edenbridge Pharmaceuticals LLC.	32c4372e-54ea-4fc8-b9f8-827fa4c8edd3	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
BUMETANIDE	BUMETANIDE	Lupin Pharmaceuticals, Inc.	2c71a17e-ed76-4545-b23e-9f4997b13c2f	2025-11-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BUMETANIDE generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	12b9489a-b16b-4504-a660-e66fd5261069	2025-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	A-S Medication Solutions	14e92f79-2c7b-4ab9-844f-e7bd1964f8b2	2025-11-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	b2dcdf9b-70b9-493f-99b4-fc7dcc31939a	2025-10-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumex	BUMETANIDE	Validus Pharmaceuticals LLC	32dfbea3-eb2b-4070-8605-57ce3e6d5a2f	2025-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Bryant Ranch Prepack	6b5450f2-ae91-48b6-ad83-261bdfcf47ac	2025-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bumetanide generic name: BUMETANIDE
Bumetanide	BUMETANIDE	Upsher-Smith Laboratories, LLC	ff5dc8c6-b2f2-41d3-8e56-a953aa721b59	2025-07-15	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.