FDA.reportPublic FDA data

Application 085855

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001A-METHAPREDMETHYLPREDNISOLONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 125MG BASE/VIALNoNo

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
A085855-001A-METHAPREDMETHYLPREDNISOLONE SODIUM SUCCINATEEQ 125MG BASE/VIALINJECTABLE / 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 UTC2022-09A085855-001A-METHAPREDEQ 125MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085855-001A-METHAPREDEQ 125MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085855-001A-METHAPREDEQ 125MG BASE/VIALINJECTABLE / 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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.ae524bdb-9fd0-49f9-802d-465a374c175b2026-09-08Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
METHYLPREDNISOLONE SODIUM SUCCINATEMETHYLPREDNISOLONE SODIUM SUCCINATEHF Acquisition Co LLC, DBA HealthFirst559427ac-9fc6-96f5-e063-6294a90a0b302026-07-24Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATESportpharm LLC0cb0ba76-067f-46c4-a5d8-b585d5ecafe32026-07-23Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATECardinal Health 107, LLC68ef8ec4-16de-4a8c-8696-b093596603802026-07-17Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEPharmacia & Upjohn Company LLC7271310c-7764-4812-aa30-a5e90987c7a92026-06-25Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEEugia US LLC2035f00e-2299-473a-b004-cb93f541cfa92026-06-12Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATEHenry Schein, Inc.ea2f9b6f-2375-40a6-8b97-b607b9f3ac632026-06-04Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEA-S Medication Solutions8e5997ed-f4a5-43f7-abbd-c8e2219fe0e92026-05-29Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATECardinal Health 107, LLC2af28649-2553-4bcc-9cb1-c73f7cec76d52026-05-20Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone sodium succinateMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.f339882f-c380-4022-bdcd-94556a7926aa2026-04-15Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATEHenry Schein, Inc.decceb81-e922-4b72-a278-3ed80f4adb042026-03-18Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEHikma Pharmaceuticals USA Inc.060bcf13-ce9e-488c-ad43-9d66abb23b182026-02-17Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATECivica, Inc.2e6020f5-a486-41cc-8956-58b5f6751aa22026-02-17Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEHikma Pharmaceuticals USA Inc.05d95a56-b03a-4d5b-9877-2853ac470fa12026-02-13Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Methylprednisolone Sodium SuccinateMETHYLPREDNISOLONE SODIUM SUCCINATEHikma Pharmaceuticals USA Inc.2e540674-0915-4498-8e2b-751c7e97532a2026-02-13Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEREMEDYREPACK INC.1d5ef347-2e9a-432f-9a88-a7c4ba3002672026-01-30Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
Solu-MedrolMETHYLPREDNISOLONE SODIUM SUCCINATECardinal Health 107, LLC7e38b09c-da41-4ee3-8f99-812d3276d5512025-12-19Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEProPharma Distribution42df21df-9284-4505-e063-6294a90a70242025-12-18Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEPharmacia & Upjohn Company LLCcd99be87-c8d9-48d6-a8e5-e081052e3f192025-12-02Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE
SOLU-MEDROLMETHYLPREDNISOLONE SODIUM SUCCINATEProPharma Distribution38698075-ac58-b5a4-e063-6294a90a78482025-07-18Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE SODIUM SUCCINATE

Reported adverse events (FAERS/openFDA)#

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