FDA.reportPublic FDA data

Application 217917

Type
ANDA
Sponsor
BIONPHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL25MGNoNo
002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL50MGNoNo
003FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL100MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217917-001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE25MGTABLET / ORALAB2024-01-22
A217917-002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE50MGTABLET / ORALAB2024-01-22
A217917-003FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE100MGTABLET / ORALAB2024-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217917-001AB
A217917-002AB
A217917-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217917-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2024-01-22a50c72e98297…
2026-08-01 22:54:322026-06A217917-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2024-01-22a50c72e98297…
2026-08-01 22:54:322026-06A217917-003FLUVOXAMINE MALEATE100MGTABLET / ORALAB2024-01-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217917-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217917-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A217917-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluvoxamine maleateFLUVOXAMINE MALEATEBryant Ranch Prepackc3d59ca9-dd42-4b1c-bd2d-23eb507598b82026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917
Fluvoxamine maleateFLUVOXAMINE MALEATEA-S Medication Solutions35b377d9-5b7a-4d8e-b6c1-4291d02f5dae2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917
Fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.642b7b5e-9f1c-479b-b9b3-bf06774f7b602025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917
Fluvoxamine maleateFLUVOXAMINE MALEATEBionpharma Inc.191912e6-b3c8-be1a-e063-6394a90a8dd42025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917
Fluvoxamine maleateFLUVOXAMINE MALEATEBionpharma Inc.2df4f9cf-5803-d8ea-e063-6394a90ad8552025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917