FDA.reportPublic FDA data

Application 086666

Type
ANDA
Sponsor
BEL MAR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001M-PREDROLMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION40MG/MLNoNo

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
A086666-001M-PREDROLMETHYLPREDNISOLONE ACETATE40MG/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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A086666-001M-PREDROL40MG/MLINJECTABLE / INJECTIONApproved before 1982a50c72e98297…

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 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