Application 075888

Type
ANDA
Sponsor
UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL25MGNoNo
002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL50MGNoNo
003FLUVOXAMINE MALEATEFLUVOXAMINE MALEATETABLET;ORAL100MGNoYes

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
A075888-001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-29
A075888-002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-29
A075888-003FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075888-001AB
A075888-002AB
A075888-003AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075888-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2000-11-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075888-003FLUVOXAMINE MALEATE100MGTABLET / ORALABRS2000-11-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075888-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2000-11-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075888-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075888-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075888-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075888-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075888-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075888-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075888-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075888-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075888-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075888-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075888-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075888-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075888-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075888-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075888-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075888-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075888-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075888-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075888-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075888-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075888-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075888-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075888-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075888-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075888-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075888-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075888-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075888-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075888-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075888-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075888-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075888-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075888-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075888-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075888-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075888-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075888-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075888-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075888-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075888-001AB18072bd15b7f6…

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluvoxamine MaleateFLUVOXAMINE MALEATEAmerican Health Packaging0b107225-ed5a-4461-9184-f3f2bad1892f2026-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.5198b1c8-8dd6-4b8f-bd85-294ac468af532026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.a4e0212a-ce68-4466-a0e4-f87d5d9ff0b32026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals, Inc.b5b2128d-2363-4966-971f-83219755ecd72026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleateFLUVOXAMINE MALEATEBryant Ranch Prepackc3d59ca9-dd42-4b1c-bd2d-23eb507598b82026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack4239fc32-e5cb-4393-b90c-742db42b5d072026-01-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack47daea9e-545d-4a67-b2b2-d12c3c98734b2026-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.88b5207a-d87b-4541-ac6b-aa1c51715fcf2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEAvKARE4527a684-51c0-1858-e063-6394a90a26312025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEAjanta Pharma USA Inc.0a6836ab-bd0e-410b-82af-07720e3865322025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleateFLUVOXAMINE MALEATEA-S Medication Solutions35b377d9-5b7a-4d8e-b6c1-4291d02f5dae2025-10-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEPD-Rx Pharmaceuticals, Inc.9972efbb-46cd-45b7-b71c-35032311b70c2025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEApotex Corp6eeb14df-6fcf-a737-5359-5744eb4accea2025-09-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.642b7b5e-9f1c-479b-b9b3-bf06774f7b602025-09-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATECamber Pharmaceuticals, Inc.e5574f41-d4df-42d5-baae-b317fb7c88bf2025-08-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEANI Pharmaceuticals, Inc.7ecd83ec-88f5-4f85-9cc2-9068375d88202025-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE
fluvoxamine maleateFLUVOXAMINE MALEATEA-S Medication Solutionsddc9e7e8-f041-43bb-970b-cd4b303676372025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine MaleateFLUVOXAMINE MALEATEActavis Pharma, Inc.8bbd7e39-b9ab-4716-9522-aa8c4b92210e2025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine Maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleateFLUVOXAMINE MALEATEBionpharma Inc.191912e6-b3c8-be1a-e063-6394a90a8dd42025-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE
Fluvoxamine maleateFLUVOXAMINE MALEATEBionpharma Inc.2df4f9cf-5803-d8ea-e063-6394a90ad8552025-02-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fluvoxamine maleate
generic name: FLUVOXAMINE MALEATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0017fluvoxamine maleatefluvoxamine maleateEon Labs, Inc.ANDACurrent
0185-0027fluvoxamine maleatefluvoxamine maleateEon Labs, Inc.ANDACurrent
0185-0157fluvoxamine maleatefluvoxamine maleateEon Labs, Inc.ANDACurrent
0832-1670Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1670Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1670Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1670Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1671Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1671Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1671Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1671Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1672Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1672Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1672Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
0832-1672Fluvoxamine maleateFluvoxamine maleateUpsher-Smith Laboratories, LLCANDACurrent
63629-4676fluvoxamine maleatefluvoxamine maleateBryant Ranch PrepackANDACurrent
70518-3153Fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.ANDACurrent
70518-3153Fluvoxamine maleateFluvoxamine maleateREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44274ORIG2007-05-09
8819ORIG2000-11-29