FDA.reportPublic FDA data

Application 080336

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002PREDNISONEPREDNISONETABLET;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
A080336-002PREDNISONEPREDNISONE5MGTABLET / 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 UTC2022-09A080336-002PREDNISONE5MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A080336-002PREDNISONE5MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A080336-002PREDNISONE5MGTABLET / 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 13 · 244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PrednisonePREDNISONEBryant Ranch Prepack290a91e5-22ae-4d62-ab34-39a3117002e22026-09-08Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.4750028a-30ad-420a-8e6b-06dc2429d4332026-09-08Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack0062fcc7-aa08-4990-9d33-d798725907f12026-09-08Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PredniSONEPREDNISONEREMEDYREPACK INC.7db793b4-5768-4e9a-a47b-1ebbfed740012026-09-03Warnings, Adverse reactionsName fallback
brand name: PredniSONE
generic name: PREDNISONE
PREDNISONEPREDNISONEREMEDYREPACK INC.0993b354-d936-472b-bafc-114f0f81bfb02026-09-01Warnings, Adverse reactionsName fallback
brand name: PREDNISONE
generic name: PREDNISONE
PredniSONEPREDNISONEREMEDYREPACK INC.94715919-70bd-46c9-95fc-e151adf39cf92026-08-31Warnings, Adverse reactionsName fallback
brand name: PredniSONE
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.23b12d22-97d6-426e-bf9c-dd6c2ff773702026-08-26Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PredniSONE Tablets, USP, 20 mgPREDNISONEPD-Rx Pharmaceuticals, Inc.6b360c1f-c862-47ee-a40e-3903c2d6162f2026-08-21Warnings, Adverse reactionsName fallback
generic name: PREDNISONE
PredniSONEPREDNISONEPreferred Pharmaceuticals Inc.02158832-550b-4855-a5c5-6abbf13ed6f02026-08-20Warnings, Adverse reactionsName fallback
brand name: PredniSONE
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepackc60a07f9-ed9f-4434-a69d-2e2fea4843fd2026-08-20Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEREMEDYREPACK INC.746b0bcd-122e-4ea8-a824-28415073a38e2026-08-20Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEBryant Ranch Prepack7ea7f6a9-78ef-42fe-baac-f817da3976fb2026-08-20Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONEPreferred Pharmaceuticals Inc.1e74ac55-4a48-4bf5-bfed-36c0fa37dd9f2026-08-19Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEPreferred Pharmaceuticals Inc.fa75f5ce-8a74-4873-811f-7d9d9beec08f2026-08-19Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEPreferred Pharmaceuticals Inc.930b5eea-3ec8-47df-a76d-1e0bc0b5c5b22026-08-19Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONEPreferred Pharmaceuticals, Inc.f89bd1dc-88cd-4aef-a7ae-6310f38a34232026-08-19Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
PrednisonePREDNISONEMajor Pharmaceuticals57b98930-92ab-4b77-a033-ae9895ee718a2026-08-19Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE
prednisonePREDNISONEPreferred Pharmaceuticals Inc.ce7663a7-4c91-4790-aa43-96f259b3bb182026-08-19Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
prednisonePREDNISONEREMEDYREPACK INC.e47a0448-331f-4846-8e63-c52c3afa274b2026-08-11Warnings, Adverse reactionsName fallback
brand name: prednisone
generic name: PREDNISONE
PrednisonePREDNISONECardinal Health 107, LLC568b8880-7997-4786-8c57-28816ce526552026-08-07Warnings, Adverse reactionsName fallback
brand name: Prednisone
generic name: PREDNISONE

Reported adverse events (FAERS/openFDA)#

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