FDA.reportPublic FDA data

Application 087135

Type
ANDA
Sponsor
BEL MAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001M-PREDROLMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION80MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A087135-001M-PREDROLMETHYLPREDNISOLONE ACETATE80MG/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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A087135-001M-PREDROL80MG/MLINJECTABLE / INJECTIONApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087135-001M-PREDROL80MG/MLINJECTABLE / INJECTIONApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087135-001M-PREDROL80MG/MLINJECTABLE / INJECTIONApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087135-001M-PREDROL80MG/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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methylprednisolone AcetateMETHYLPREDNISOLONE ACETATEEugia US LLCa0cbcdb5-f657-49f7-8f86-cc5959d69db02026-04-21Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
methylprednisolone acetateMETHYLPREDNISOLONE ACETATESportpharm LLC904b098c-9068-42ed-958f-6ab78ea42b1f2026-04-01Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone AcetateMETHYLPREDNISOLONE ACETATECaplin Steriles Limited23f98766-7571-49cb-8c1a-58fabba539652026-02-06Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATESportpharm LLC62f4339a-a971-414d-b407-ef030fe4f9892026-02-06Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Depo-MedrolMETHYLPREDNISOLONE ACETATEPharmacia & Upjohn Company LLC823b0010-2b57-4e76-b5ac-4a8c2963438f2026-01-21Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Depo-MedrolMETHYLPREDNISOLONE ACETATEPharmacia & Upjohn Company LLC9a7b3837-e038-48bf-97e9-78ad463760dc2026-01-21Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals NY LLC8ea42650-21cd-49e4-92c8-48f2eeaf95bc2026-01-19Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals LLC3184a75e-61c5-4281-abf0-4eab861ca0092026-01-19Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals LLCde12f38c-ffa1-4d62-b9cb-238a263f6fea2025-12-31Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals LLCd944240d-2c19-46ba-ad4f-3fbee7b8629c2025-12-15Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Depo-MedrolMETHYLPREDNISOLONE ACETATEPharmacia & Upjohn Company LLCbf1b104d-85cb-414d-a366-78068c82c8832025-12-01Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEA-S Medication Solutions1084208f-3b86-4aef-8247-5b6ed6cd50c72025-11-07Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
DEPO-MEDROLMETHYLPREDNISOLONE ACETATEA-S Medication Solutionscb457bef-8823-4f3c-987b-eb0922494c462025-11-06Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
DEPO-MEDROLMETHYLPREDNISOLONE ACETATEA-S Medication Solutionsd75f6751-9ac3-416f-8470-6c011aacf7552025-11-05Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
DEPO-MEDROLMETHYLPREDNISOLONE ACETATEA-S Medication Solutionse8209047-c1e6-4081-a6d3-c603d9ee4f142025-10-27Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
methylprednisolone acetateMETHYLPREDNISOLONE ACETATESagent Pharmaceuticalsf98314ea-a4e4-4f78-987b-3e9b45a08bb42025-03-02Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEA-S Medication Solutions2f47d739-c39f-47c2-9e3c-1aef2cf201b12024-06-03Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
DEPO-MEDROLMETHYLPREDNISOLONE ACETATEA-S Medication Solutionsaa151d12-bd33-4d26-848f-2195172c97002024-06-03Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Medroloan SUIKMETHYLPREDNISOLONE ACETATEAsclemed USA, Inc.7867127f-aab1-494f-8c3d-e521ed578c3a2022-12-09Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE
Medroloan II SUIKMETHYLPREDNISOLONE ACETATEAsclemed USA, Inc.18dacdba-793c-490d-aa73-9e76bec41fae2022-12-09Warnings, Adverse reactionsName fallback
generic name: METHYLPREDNISOLONE ACETATE

Reported adverse events (FAERS/openFDA)#

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