Application 209916

Type: ANDA
Sponsor: UPSHER SMITH LABS

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
A209916-001	BUMETANIDE	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23
A209916-002	BUMETANIDE	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23
A209916-003	BUMETANIDE	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209916-001	AB
A209916-002	AB
A209916-003	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.

Product history page 1 of 4 · 129 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
2026-09-14 22:38:34	2026-08	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209916-002	BUMETANIDE	1MG	TABLET / ORAL	AB	2018-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209916-003	BUMETANIDE	2MG	TABLET / ORAL	AB	2018-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209916-001	BUMETANIDE	0.5MG	TABLET / ORAL	AB	2018-01-23	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A209916-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209916-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209916-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A209916-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209916-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209916-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A209916-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209916-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209916-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209916-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209916-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209916-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209916-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209916-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209916-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209916-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209916-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209916-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209916-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209916-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209916-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209916-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209916-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209916-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209916-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209916-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209916-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209916-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209916-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209916-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209916-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209916-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209916-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A209916-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209916-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209916-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209916-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209916-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A209916-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A209916-003	AB	1	`f41ea6bd6efb…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bumetanide	BUMETANIDE	A-S Medication Solutions	dfa1f77d-8209-48e9-a6c7-d3b4725a97db	2024-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209916 application number: ANDA209916

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0832-0540	Bumetanide	BUMETANIDE	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0541	Bumetanide	BUMETANIDE	Upsher-Smith Laboratories, LLC	ANDA	Current
0832-0542	Bumetanide	BUMETANIDE	Upsher-Smith Laboratories, LLC	ANDA	Current