FDA.reportPublic FDA data

Application 219145

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION80MG/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
A219145-001METHYLPREDNISOLONE ACETATEMETHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2025-04-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A219145-001AB

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
2026-02-19 14:30 UTC2026-02A219145-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2025-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219145-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2025-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A219145-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2025-04-166a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219145-001METHYLPREDNISOLONE ACETATE80MG/MLINJECTABLE / INJECTIONAB2025-04-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A219145-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A219145-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A219145-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219145-001AB1a50c72e98297…

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
brand name: Methylprednisolone Acetate
generic name: METHYLPREDNISOLONE ACETATE
methylprednisolone acetateMETHYLPREDNISOLONE ACETATESportpharm LLC904b098c-9068-42ed-958f-6ab78ea42b1f2026-04-01Warnings, Adverse reactionsName fallback
brand name: methylprednisolone acetate
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone AcetateMETHYLPREDNISOLONE ACETATECaplin Steriles Limited23f98766-7571-49cb-8c1a-58fabba539652026-02-06Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone Acetate
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATESportpharm LLC62f4339a-a971-414d-b407-ef030fe4f9892026-02-06Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone acetate
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
brand name: Methylprednisolone acetate
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals LLC3184a75e-61c5-4281-abf0-4eab861ca0092026-01-19Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone acetate
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals LLCde12f38c-ffa1-4d62-b9cb-238a263f6fea2025-12-31Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone acetate
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEAmneal Pharmaceuticals LLCd944240d-2c19-46ba-ad4f-3fbee7b8629c2025-12-15Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone acetate
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
brand name: Methylprednisolone acetate
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
brand name: methylprednisolone acetate
generic name: METHYLPREDNISOLONE ACETATE
Methylprednisolone acetateMETHYLPREDNISOLONE ACETATEA-S Medication Solutions2f47d739-c39f-47c2-9e3c-1aef2cf201b12024-06-03Warnings, Adverse reactionsName fallback
brand name: Methylprednisolone acetate
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