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 3 of 13 · 245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisonePREDNISONEBryant Ranch Prepackfbfd4e2b-3c8f-43c8-bcbe-da1ac4be75c52026-05-04Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEAphena Pharma Solutions - Tennessee, LLC18818282-68aa-82e9-e063-6394a90aef542026-05-01Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONEProficient Rx LP4b37ada5-1f22-46d5-a794-fd1477c0eb9b2026-05-01Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepacke4c1c8c5-0aa1-4531-aa7a-8567ac8dcba82026-04-29Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PREDNISONEPREDNISONECoupler LLC50734a48-807d-cc00-e063-6294a90a4dae2026-04-27Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
prednisonePREDNISONESportpharm LLC5dde7256-d3b8-400d-a0eb-c60078bfc5d92026-04-24Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEAmneal Pharmaceuticals NY LLC0740ef68-7641-432e-bd46-4710687fc9d72026-04-14Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEREMEDYREPACK INC.4bd86b2f-75cb-4711-85e2-b81ed947cb132026-04-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.e9a74862-6a3b-4247-837a-389761b5c3522026-04-13Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.e47a0448-331f-4846-8e63-c52c3afa274b2026-04-13Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.b540f4af-8f07-4c56-b151-d759440c514a2026-04-13Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEBryant Ranch Prepack70d05ed7-5c4e-4cd1-84cd-0dbe90692c542026-04-09Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.af5d0f73-2aef-4db1-ae25-6d465c9f0ca12026-04-08Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONENorthwind Health Company, LLCfbd3f0c3-06b3-c9b4-e053-6294a90a6fdd2026-04-07Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.6b360c1f-c862-47ee-a40e-3903c2d6162f2026-04-06Warnings, Adverse reactionsName fallback
generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.251e9fe7-b1f5-4b5b-b5fa-8c8be43e284e2026-03-27Warnings, Adverse reactionsName fallback
generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.3befbdc5-7d20-41b6-ad80-98e1c6b8caf52026-03-27Warnings, Adverse reactionsName fallback
generic name: PREDNISONE
PREDNISONEPREDNISONEA-S Medication Solutions53c66f70-58fd-4d4c-b054-e5cefdc0c6372026-03-26Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PredniSONE Tablets, USP, 5 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.d6df3295-3118-49af-be05-b1fab0d4adaa2026-03-25Warnings, Adverse reactionsName fallback
generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.14d50f54-410b-45b2-a639-31498ceaf8542026-03-25Warnings, Adverse reactionsName fallback
generic name: PREDNISONE