FDA.reportPublic FDA data

Application 218312

Type
ANDA
Sponsor
BRIGHTGENE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FONDAPARINUX SODIUMFONDAPARINUX SODIUMSOLUTION;SUBCUTANEOUS2.5MG/0.5ML (2.5MG/0.5ML)NoNo

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218312-001FONDAPARINUX SODIUMFONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUS2024-12-18

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
2026-02-19 14:30 UTC2026-02A218312-001FONDAPARINUX SODIUM2.5MG/0.5MLSOLUTION / SUBCUTANEOUS2024-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A218312-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUS2024-12-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A218312-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2024-12-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218312-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2024-12-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218312-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2024-12-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218312-001FONDAPARINUX SODIUM2.5MG/0.5MLINJECTABLE / SUBCUTANEOUSAP2024-12-1803ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218312-001FONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML)SOLUTION / SUBCUTANEOUS2024-12-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A218312-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A218312-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A218312-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A218312-001AP103ed91905a0d…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fondaparinux sodiumFONDAPARINUX SODIUMZydus Pharmaceuticals (USA) Inc.dffbf7c9-495e-4a33-ac76-57b52f014fc22025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fondaparinux sodium
generic name: FONDAPARINUX SODIUM
Fondaparinux SodiumFONDAPARINUX SODIUMSandoz Inc.baa50757-a927-4d56-a933-5d7798fe6ab02025-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fondaparinux Sodium
generic name: FONDAPARINUX SODIUM
ArixtraFONDAPARINUX SODIUMMylan Institutional LLCd3b30c68-cf45-4b46-8ba6-72090f7ba01a2024-12-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FONDAPARINUX SODIUM
FONDAPARINUX SODIUMFONDAPARINUX SODIUMEugia US LLC8ea61d0d-4403-4d9f-a946-85a459cc0aa02024-01-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FONDAPARINUX SODIUM
generic name: FONDAPARINUX SODIUM
Fondaparinux SodiumFONDAPARINUX SODIUMDr. Reddy's Laboratories Limited49e0d7bc-3f49-849b-c77c-98682d1c0d192021-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fondaparinux Sodium
generic name: FONDAPARINUX SODIUM
fondaparinux sodiumFONDAPARINUX SODIUMItalfarmaco S.p.A58789e3d-e5bc-4c2e-a527-495a252fcecd2020-10-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: fondaparinux sodium
generic name: FONDAPARINUX SODIUM
Fondaparinux SodiumFONDAPARINUX SODIUMMylan Institutional LLC4b65f642-87f7-4da5-a9c9-02cd1f8d9d162020-08-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fondaparinux Sodium
generic name: FONDAPARINUX SODIUM