FDA.reportPublic FDA data

Application 086120

Type
ANDA
Sponsor
WATSON LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001WARFARIN SODIUMWARFARIN SODIUMTABLET;ORAL2.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A086120-001WARFARIN SODIUMWARFARIN SODIUM2.5MGTABLET / ORAL1982-08-17

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A086120-001WARFARIN SODIUM2.5MGTABLET / ORAL1982-08-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A086120-001WARFARIN SODIUM2.5MGTABLET / ORAL1982-08-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A086120-001WARFARIN SODIUM2.5MGTABLET / ORAL1982-08-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A086120-001WARFARIN SODIUM2.5MGTABLET / ORAL1982-08-17a50c72e98297…

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 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Warfarin SodiumWARFARINCoupler LLC5a5b5e3a-6556-a542-e063-6294a90a6d3f2026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARIN SODIUMCardinal Health 107, LLC7c4deb97-9966-4c8e-9ba6-bb260b71e1302026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
generic name: WARFARIN SODIUM
Warfarin SodiumWARFARINCoupler LLC598e5e2e-9264-8371-e063-6394a90aaf182026-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.bd6ea120-5d1c-4815-94f2-81e28dc6b7a92026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
generic name: WARFARIN SODIUM
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.724b0061-f42a-4008-a078-09c800ee97852026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
generic name: WARFARIN SODIUM
Warfarin SodiumWARFARINREMEDYREPACK INC.d7fb4290-ed37-4ed3-ae51-c400191961dc2026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARINREMEDYREPACK INC.51e98fb6-ba76-497e-95d8-fe895ef0b7ed2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARINREMEDYREPACK INC.a4cf3107-5646-4b91-8aae-94548e4409ef2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARINREMEDYREPACK INC.2fb8b8d5-f643-4069-8e47-5eae31a8fbc82026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARINREMEDYREPACK INC.884cdbf6-0a52-4126-8e14-b0d7c9367e332026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARINREMEDYREPACK INC.8eddba53-19c4-411b-b0d4-cb2f948ba1252026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARINREMEDYREPACK INC.2cbcc99d-9107-4d39-a1e9-e19305de8b5d2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARINREMEDYREPACK INC.8ee94789-72d2-4c42-9dbd-0501e9767d972026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARINREMEDYREPACK INC.545ec40d-2db1-4581-b3ec-ce195e5f54002026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.f5fb1a5f-0dda-4f47-8683-ea63ac88a69d2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
generic name: WARFARIN SODIUM
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.1244c338-9140-425a-bf2a-9da6b4ac02872026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
generic name: WARFARIN SODIUM
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.d6083d68-4360-4d47-a1b2-1eb2763024bb2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
generic name: WARFARIN SODIUM
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.4dc2d94e-f856-47da-9d44-24773d97eb872026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
generic name: WARFARIN SODIUM
Warfarin SodiumWARFARIN SODIUMREMEDYREPACK INC.ba65ae56-ca3b-4895-9938-1dde2c3d34bf2026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
generic name: WARFARIN SODIUM
Warfarin SodiumWARFARIN SODIUMA-S Medication Solutions8cd0e744-b499-4344-b1db-59f85950e1692026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Warfarin Sodium
generic name: WARFARIN SODIUM

Reported adverse events (FAERS/openFDA)#

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