NDC 57894-201

Icotyde 200 mg tablet, film coated

On the label: Janssen Biotech, Inc..

Italy: 1Belgium: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Janssen Cilag SpABorgo San Michele, ItalyMakes it, tests it, packages it and labels it Problems found, fixed voluntarilySep 27, 2024 · 6 inspections
Janssen Pharmaceutica NVGeel, BelgiumMakes the active ingredient and tests it Problems found, fixed voluntarilyMar 26, 2024 · 7 inspections
Johnson & Johnson Private LimitedMumbai, IndiaTests it No problems foundApr 30, 2025 · 4 inspections
Jom Pharmaceutical Services, LLCShepherdsville, KY, United StatesPackages it and labels it No problems foundMay 12, 2026 · 1 inspection
SGS India Private LimitedNavi Mumbai, IndiaTests it No problems foundJul 5, 2024 · 2 inspections

Product details

Generic drug
Icotrokinra: every company that makes it
Form
tablet, film coated, oral
Strength
200 mg
Approval
NDA NDA220149
On the market since
Mar 17, 2026
Package NDCs
57894-201-01 57894-201-07 57894-201-30
Official label
DailyMed (National Library of Medicine), updated Mar 17, 2026

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