Application 214319

Type
ANDA
Sponsor
SUN PHARM INDS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SUGAMMADEXSUGAMMADEXINJECTABLE;INJECTIONEQ 200MG BASE/2ML (EQ 100MG BASE/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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
sugammadexSUGAMMADEXSun Pharmaceutical Industries, Inc.55b2eb4e-4d77-c555-e063-6294a90abf9e2026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214319
application number: ANDA214319