FDA.reportPublic FDA data

Application 073563

Type
ANDA
Sponsor
SOCORRO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFLUNISALDIFLUNISALTABLET;ORAL500MGNoNo

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
A073563-001DIFLUNISALDIFLUNISAL500MGTABLET / ORAL1992-11-27

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 22:54:322026-06A073563-001DIFLUNISAL500MGTABLET / ORAL1992-11-27a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DolobidDIFLUNISALINA Pharmaceutics Inc725234b2-0e23-45c3-a42d-eb4e62273f9b2025-10-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: DIFLUNISAL
DiflunisalDIFLUNISALZydus Lifesciences Limitedd7a722be-4612-4b2e-827d-56fb5eef0aae2024-11-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diflunisal
generic name: DIFLUNISAL
DiflunisalDIFLUNISALChartwell RX, LLC2043bab8-87c9-45ce-88c7-383f0d4c4b642024-10-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diflunisal
generic name: DIFLUNISAL
diflunisalDIFLUNISALHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.666f89b4-fd81-420a-a390-eb1cd4014f612024-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: diflunisal
generic name: DIFLUNISAL
DiflunisalDIFLUNISALZydus Pharmaceuticals (USA) Inc.5baf9f35-6b5e-4666-a14a-ac0f9d4e9f762024-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diflunisal
generic name: DIFLUNISAL
DiflunisalDIFLUNISALTeva Pharmaceuticals USA, Inc.7a78bb38-14d8-4a90-b883-482d4cebf7162024-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Diflunisal
generic name: DIFLUNISAL