Application 217917

Type: ANDA
Sponsor: BIONPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	TABLET;ORAL	25MG	No	No
002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	TABLET;ORAL	50MG	No	No
003	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	TABLET;ORAL	100MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A217917-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22
A217917-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22
A217917-003	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217917-001	AB
A217917-002	AB
A217917-003	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 2 · 54 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
2026-08-18 06:07:40	2026-07	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A217917-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217917-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217917-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217917-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217917-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217917-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217917-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217917-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217917-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217917-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217917-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217917-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217917-001	AB	1	`1e350fbaab3a…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Bryant Ranch Prepack	c3d59ca9-dd42-4b1c-bd2d-23eb507598b8	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917
Fluvoxamine maleate	FLUVOXAMINE MALEATE	A-S Medication Solutions	35b377d9-5b7a-4d8e-b6c1-4291d02f5dae	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Preferred Pharmaceuticals Inc.	642b7b5e-9f1c-479b-b9b3-bf06774f7b60	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Bionpharma Inc.	191912e6-b3c8-be1a-e063-6394a90a8dd4	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Bionpharma Inc.	2df4f9cf-5803-d8ea-e063-6394a90ad855	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917