FDA.reportPublic FDA data

Application 080327

Type
ANDA
Sponsor
ROXANE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002PREDNISOLONEPREDNISOLONETABLET;ORAL5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A080327-002PREDNISOLONEPREDNISOLONE5MGTABLET / ORALApproved before 1982

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A080327-002PREDNISOLONE5MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080327-002PREDNISOLONE5MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080327-002PREDNISOLONE5MGTABLET / ORALApproved before 1982a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisolonePREDNISOLONE ORALTRUPHARMA, LLC4f83514d-5342-4748-a0d3-b0306ca303c82026-09-02Warnings, Adverse reactionsName fallback
brand name: Prednisolone
PrednisolonePREDNISOLONE ORALTulex Pharmaceuticals Inc757b41c4-a0fe-4a09-8816-a4cdb7558f412026-07-08Warnings, Adverse reactionsName fallback
brand name: Prednisolone
PrednisolonePREDNISOLONEA-S Medication Solutions35f0b197-c3ae-445a-8da7-9ffcd4472e052026-01-23Warnings, Adverse reactionsName fallback
brand name: Prednisolone
generic name: PREDNISOLONE
PREDNISOLONEPREDNISOLONEZhejiang Xianju Pharmaceutical Co., Ltd.52e6e21d-94b8-41a0-8d13-371c0e66bcee2026-01-05Warnings, Adverse reactionsName fallback
brand name: PREDNISOLONE
generic name: PREDNISOLONE
PrednisolonePREDNISOLONE ORALChartwell Governmental & Specialty RX, LLC.2dac9898-6492-4f34-ad86-83a902e0fe0b2025-11-18Warnings, Adverse reactionsName fallback
brand name: Prednisolone
PrednisolonePREDNISOLONE ORAL SOLUTIONHeritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.b079834f-9aa3-4db9-bd53-de28e8f81c042025-02-18Warnings, Adverse reactionsName fallback
brand name: Prednisolone
PrednisolonePREDNISOLONEPAI Holdings, LLC dba PAI Pharmacebd7b5b-8e9f-4de9-9fcf-8ee0661fede32024-08-19Warnings, Adverse reactionsName fallback
brand name: Prednisolone
generic name: PREDNISOLONE
PREDNISOLONEPREDNISOLONEHisun Pharmaceuticals USA, Inc.16d4e064-66d3-4497-8c7d-3aa355f91e1d2024-08-15Warnings, Adverse reactionsName fallback
brand name: PREDNISOLONE
generic name: PREDNISOLONE
PrednisolonePREDNISOLONEChartwell RX, LLC2e965355-f7f2-4dd3-9c5c-1524c6f39c912024-06-17Warnings, Adverse reactionsName fallback
brand name: Prednisolone
generic name: PREDNISOLONE
PrednisolonePREDNISOLONE ORALChartwell RX, LLCaa40f582-cced-4e6e-90f0-10ab310ab2a72024-06-03Warnings, Adverse reactionsName fallback
brand name: Prednisolone
PREDNISOLONEPREDNISOLONEAurobindo Pharma Limited070f1937-50a5-457f-bef5-4e597014e26d2024-02-16Warnings, Adverse reactionsName fallback
brand name: PREDNISOLONE
generic name: PREDNISOLONE
PrednisoLONEPREDNISOLONELannett Company, Inc.86652e2d-664a-4388-a611-c2a9aa4a4bc82024-02-14Warnings, Adverse reactionsName fallback
brand name: PrednisoLONE
generic name: PREDNISOLONE

Reported adverse events (FAERS/openFDA)#

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