FDA.reportPublic FDA data

Application 089894

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUINIDINE GLUCONATEQUINIDINE GLUCONATETABLET, EXTENDED RELEASE;ORAL324MGNoNo

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
A089894-001QUINIDINE GLUCONATEQUINIDINE GLUCONATE324MGTABLET, EXTENDED RELEASE / ORAL1988-12-15

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 22:54:322026-06A089894-001QUINIDINE GLUCONATE324MGTABLET, EXTENDED RELEASE / ORAL1988-12-15a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quinidine GluconateQUINIDINE GLUCONATEGolden State Medical Supplyad2ad985-cca2-25b5-e053-2995a90a402f2024-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quinidine Gluconate
generic name: QUINIDINE GLUCONATE
Quinidine gluconateQUINIDINE GLUONATEEywa Pharma Inc4db375a3-0cff-4fa7-af7a-2a49e0b922d02021-12-29Warnings, Adverse reactionsName fallback
brand name: Quinidine gluconate
Quinidine GluconateQUINIDINE GLUCONATESun Pharmaceutical Industries, Inc.5023f053-fcc4-4c2c-aa59-9ec198ad185e2018-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Quinidine Gluconate
generic name: QUINIDINE GLUCONATE