FDA.reportPublic FDA data

Application 218349

Type
ANDA
Sponsor
ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EDARAVONEEDARAVONEINJECTABLE;INJECTION30MG/100ML(0.3MG/ML)NoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
edaravoneEDARAVONEXGen Pharmaceuticals DJB, Inc.a8245a98-2ccb-4062-b865-3aa348351b482026-05-28Warnings, Adverse reactionsName fallback
brand name: edaravone
generic name: EDARAVONE
RADICAVA ORSEDARAVONEShionogi Inc.0ce2c1c4-2a40-485c-b7cb-96a9b85d9d112026-05-05Warnings, Adverse reactionsName fallback
generic name: EDARAVONE
EdaravoneEDARAVONEPiramal Critical Care Inc.19862ae9-d6e1-70e6-e063-6394a90ae7492025-10-07Warnings, Adverse reactionsName fallback
brand name: Edaravone
generic name: EDARAVONE
edaravoneEDARAVONEGland Pharma Limited46452eb5-db17-400d-b25b-11844a11e7112024-05-07Warnings, Adverse reactionsName fallback
brand name: edaravone
generic name: EDARAVONE
EdaravoneEDARAVONESandoz Incae940bc6-1e6a-4b76-825c-bd2e1925e39a2023-10-01Warnings, Adverse reactionsName fallback
brand name: Edaravone
generic name: EDARAVONE