Application 218727

Type
ANDA
Sponsor
HIKMA PHARMACEUTICALS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUGAMMADEXSUGAMMADEXINJECTION;SOLUTION100MG/MLNoNo

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SugammadexSUGAMMADEXHikma Pharmaceuticals USA Inc.c8c1dccf-9be3-49b2-a5d9-46c2b9ca01932026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218727
application number: ANDA218727