FDA.reportPublic FDA data

Application 089983

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL10MGNoNo

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
A089983-001PREDNISONEPREDNISONE10MGTABLET / ORAL1989-01-12

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 22:54:322026-06A089983-001PREDNISONE10MGTABLET / ORAL1989-01-12a50c72e98297…

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 4 of 13 · 245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEA-S Medication Solutionsb5b088b9-8f90-468f-b7a4-a5274aa0aec92026-03-19Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PREDNISONEPREDNISONEDIRECT RX2a053775-6f6a-455e-b9a8-8b60e6062db32026-03-17Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PREDNISONEPREDNISONEA-S Medication Solutionse753e2bc-acca-46eb-888c-ae72fcac6ca42026-03-13Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PREDNISONEPREDNISONEA-S Medication Solutionsa8f6298a-1084-4226-bfd9-a543a26ad2e72026-03-13Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mgPREDNISONEBryant Ranch Prepack852ea185-1bda-4c89-a192-ee0f93cba4282026-03-11Warnings, Adverse reactionsName fallback
generic name: PREDNISONE
PrednisonePREDNISONEA-S Medication Solutions71295010-5adb-499b-a03a-5c78b5e79b2d2026-03-07Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONEAsclemed USA, Inc.fdcf3271-fae7-47ef-a370-adbdc0a3cf372026-03-03Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PREDNISONEPREDNISONENuCare Pharmaceuticals, Inc.2760a808-b076-5887-e063-6294a90a79ae2026-02-27Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.23b12d22-97d6-426e-bf9c-dd6c2ff773702026-02-18Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PREDNISONEPREDNISONEQPharma, Inc.4aa286e3-e272-8095-e063-6394a90ae8712026-02-13Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PREDNISONEPREDNISONEASCLEMED USA INC.bf6ebe58-e7bb-49d3-842e-3372f8ba61722026-02-05Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PREDNISONEPREDNISONENuCare Pharmaceuticals, Inc.292e2529-711c-7b74-e063-6394a90a660d2026-02-04Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
prednisonePREDNISONESportpharm LLC0e3d2f62-2b02-4ddf-a983-abb71ff31e362026-02-03Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PREDNISONEPREDNISONEREMEDYREPACK INC.ab9bffed-b1a2-4e82-ac45-bee40b41060f2026-02-02Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PrednisonePREDNISONECardinal Health 107, LLC199ed6a6-d9d9-49de-b383-5933a026591b2026-01-27Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PREDNISONEPREDNISONENuCare Pharmaceuticals, Inc.49535472-f0a7-06ef-e063-6294a90a366f2026-01-26Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PrednisonePREDNISONEA-S Medication Solutionsefe0c82b-9dd9-4729-b06f-06307867aca02026-01-20Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONECoupler LLC47bb25d2-f33c-96ce-e063-6394a90a069e2026-01-06Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONENorthwind Health Company, LLCf2a15b5d-f540-2582-e053-2995a90a591a2026-01-01Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONENorthwind Health Company, LLCfaf6c0c5-e5f4-4de5-e053-6294a90abd1a2026-01-01Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE