FDA.reportPublic FDA data

Application 089984

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREDNISONEPREDNISONETABLET;ORAL50MGNoNo

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
A089984-001PREDNISONEPREDNISONE50MGTABLET / 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 22:54:322026-06A089984-001PREDNISONE50MGTABLET / 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 2 of 13 · 245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEMajor Pharmaceuticals57b98930-92ab-4b77-a033-ae9895ee718a2026-06-16Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONESt. Mary's Medical Park Pharmacy1b3ea4cc-5bc6-ae47-e063-6294a90af13d2026-06-15Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONERedpharm Drug5407a00b-1bfb-e37d-e063-6294a90a6c412026-06-12Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPar Health USA, LLC10fe5a3b-84dc-4600-87c2-b80c97ce18cf2026-06-05Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONECoupler LLC53864d75-06ca-5c2a-e063-6394a90ad9662026-06-05Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.15230866-f547-47bf-ac7d-19afd6a41e2e2026-06-04Warnings, Adverse reactionsName fallback
generic name: PREDNISONE
PredniSONE Tablets, USP, 10 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.bb32e309-e3c7-4009-bcd4-d97545b7e9752026-06-04Warnings, Adverse reactionsName fallback
generic name: PREDNISONE
PrednisonePREDNISONEA-S Medication Solutionsaaaa3460-0239-4203-857f-0ada303c21082026-06-01Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONEBryant Ranch Prepackecc48869-3812-4440-a398-749b280620592026-05-29Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEBryant Ranch Prepack07d5e455-ac3b-4890-9619-609dd0be91062026-05-29Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEAmerican Health Packagingfdcd49a6-6cb1-49f8-9f4c-feb475c129b32026-05-21Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONECardinal Health 107, LLC1d797f3e-a46c-42bc-91bb-c570ae8ca8c22026-05-20Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.ea4070e1-080d-4feb-9561-3910c6b712dd2026-05-15Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PREDNISONEPREDNISONEST. MARY'S MEDICAL PARK PHARMACY42e0decc-4d11-e7e6-e063-6394a90a9fcc2026-05-14Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.b3b70d6f-dc44-4a54-b39b-2762f37d55752026-05-13Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEQPharma Inc11870c93-fe64-e6c9-e063-6394a90a53342026-05-11Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEQPharma Incf795ea1d-f41a-6100-e053-6394a90a63a42026-05-11Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEA-S Medication Solutionsde498de3-6ee6-4594-895e-cc69f050e34e2026-05-08Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEA-S Medication Solutionsa6811c1f-3dad-46bb-b541-fddd2ff8e5692026-05-08Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEDirect_Rxf6051257-2144-4487-e053-2995a90a973b2026-05-05Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE