FDA.reportPublic FDA data

Application 084774

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL5MGNoNo

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
A084774-001PREDNISONEPREDNISONE5MGTABLET / 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A084774-001PREDNISONE5MGTABLET / ORALApproved before 1982a50c72e98297…

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 13 · 245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
prednisonePREDNISONEREMEDYREPACK INC.5218e88b-468b-4d60-ab7e-78cca632b23a2026-07-30Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.19fdbf9f-3a64-b9fa-e063-6394a90af0862026-07-29Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1a9f00ac-ec92-4d2c-e063-6394a90ac4f62026-07-29Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.25b5958b-c151-9200-e063-6394a90af52c2026-07-29Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPD-Rx Pharmaceuticals, Inc.1349a022-639b-4494-99a2-1594c7c0f0e92026-07-21Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PREDNISONEPREDNISONENuCare Pharmaceuticals,Inc.288ecb6d-3b0b-db95-e063-6394a90a78ff2026-07-21Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PrednisonePREDNISONECardinal Health 107, LLCcdc2b903-5d86-45c1-b97c-2da48445dbdd2026-07-17Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack6c0376c4-87cf-40dc-b140-a6aac75b64f72026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack931171e2-0bdb-451e-b737-72ce3ffbed532026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack55aedced-d945-4bd2-9aa8-0f18b89a0e7f2026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepackdc3bbb97-6588-46f4-b0ad-47596874ad0c2026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack290a91e5-22ae-4d62-ab34-39a3117002e22026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack0062fcc7-aa08-4990-9d33-d798725907f12026-07-13Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PredniSONEPREDNISONEAtlantic Biologicals Corps07be390e-ef1e-4bf9-a9da-4338b5f6cfa52026-07-10Warnings, Adverse reactionsName fallback
brand name: PredniSONE
generic name: PREDNISONE
PrednisonePREDNISONEANI Pharmaceuticals, Inc.f05eb734-07e7-491c-b2e9-aae340e037502026-07-10Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONEUnit Dose Solutions, Inc.5590d36d-dbe7-1c78-e063-6294a90ad2d42026-07-01Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEAmneal Pharmaceuticals NY LLC03228706-92b9-43c9-8d73-c73aa124c58d2026-06-30Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEREMEDYREPACK INC.746b0bcd-122e-4ea8-a824-28415073a38e2026-06-24Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PredniSONEPREDNISONESt. Mary's Medical Park Pharmacy16ee689e-c7a9-3a5a-e063-6394a90a6ea22026-06-22Warnings, Adverse reactionsName fallback
brand name: PredniSONE
generic name: PREDNISONE
prednisonePREDNISONESt. Mary's Medical Park Pharmacye4437eec-eadf-7c8b-e053-2a95a90af8462026-06-21Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE