FDA.reportPublic FDA data

Application 215701

Type
ANDA
Sponsor
SHANDONG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUGAMMADEX SODIUMSUGAMMADEX SODIUMINJECTABLE;INJECTION200MG/2ML(100MG/ML)NoNo
002SUGAMMADEX SODIUMSUGAMMADEX SODIUMINJECTABLE;INJECTION500MG/5ML(100MG/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 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUGAMMADEX SODIUMSUGAMMADEX SODIUMPar Health USA, LLC579a2a1f-4d0c-4851-e063-6294a90a2be62026-07-28Warnings, Adverse reactionsName fallback
brand name: SUGAMMADEX SODIUM
generic name: SUGAMMADEX SODIUM
SUGAMMADEX SODIUMSUGAMMADEX SODIUMSTERISCIENCE SPECIALTIES PRIVATE LIMITED0379799d-b678-4eb1-8f15-7dd183ee2a6e2026-07-28Warnings, Adverse reactionsName fallback
brand name: SUGAMMADEX SODIUM
generic name: SUGAMMADEX SODIUM
SugammadexSUGAMMADEX SODIUMSagent Pharmaceuticals5b25f16e-726a-4464-88da-b188c2f4e0382026-06-16Warnings, Adverse reactionsName fallback
generic name: SUGAMMADEX SODIUM