FDA.reportPublic FDA data

Application 010255

Type
NDA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002METICORTELONEPREDNISOLONE ACETATEINJECTABLE;INJECTION25MG/MLNoNo

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
N010255-002METICORTELONEPREDNISOLONE ACETATE25MG/MLINJECTABLE / INJECTIONApproved 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 UTC2022-09N010255-002METICORTELONE25MG/MLINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010255-002METICORTELONE25MG/MLINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010255-002METICORTELONE25MG/MLINJECTABLE / INJECTIONApproved 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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PREDNISOLONE ACETATEPREDNISOLONE ACETATEA-S Medication Solutionsdd32d625-fb2f-4c51-89fe-cdccdf0201b92026-08-03Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
Prednisolone AcetatePREDNISOLONE ACETATESportpharm LLC3011a244-24a4-46ef-979a-b5d9e70762462026-07-23Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATEPREDNISOLONE ACETATESportpharm LLC02fc6f0b-d053-49e1-82de-f272dd05d5292026-04-24Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATEPREDNISOLONE ACETATEA-S Medication Solutionsf0e1b691-73ff-49ee-8a3c-71769b284ab82026-03-03Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATEPREDNISOLONE ACETATERedpharm Drug3dd0195c-8522-bbf9-e063-6394a90a9f3e2025-12-02Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PRED MILDPREDNISOLONE ACETATEAllergan, Inc.4fcce64a-94ea-4031-ad5a-c4eddc73a9102025-11-25Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATEPREDNISOLONE ACETATELupin Pharmaceuticals, Inc.75fbeab1-ce8d-4999-a875-472174be5cc62025-10-13Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
prednisolone acetatePREDNISOLONE ACETATEAmneal Pharmaceuticals NY LLC8d8e8f9b-4d65-426f-8c57-451001cdd8492025-06-12Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
Prednisolone AcetatePREDNISOLONE ACETATESandoz Inc05d205c7-8f51-46b9-a6c5-4199bc432b262024-12-30Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATEPREDNISOLONE ACETATEA-S Medication Solutions388abc87-cd5a-4e88-8675-7bf0c5ce7af52024-10-14Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATEPREDNISOLONE ACETATENuCare Pharmaceuticals,Inc.ab72cf3d-7660-41b1-e053-2995a90a7f442024-07-17Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATEPREDNISOLONE ACETATEPacific Pharma, Inc.1474d1df-70b6-4b1e-86d1-3349aa6d42fb2024-03-19Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PRED FORTEPREDNISOLONE ACETATEAllergan, Inc.00a5aa88-e361-4ea7-8922-530c738b726e2024-02-02Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
Prednisolone AcetatePREDNISOLONE ACETATEA-S Medication Solutionsb1d30a4f-4941-45a5-bd24-fea07f1bfc872023-04-30Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE
PREDNISOLONE ACETATEPREDNISOLONE ACETATEAsclemed USA, Inc.232e40a5-17c5-4cf3-9e3b-110a194ad4be2021-11-30Warnings, Adverse reactionsName fallback
generic name: PREDNISOLONE ACETATE

Reported adverse events (FAERS/openFDA)#

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