NDC 51862-462

Tolsura 65 mg capsule, gelatin coated

On the label: Mayne Pharma Inc..

Australia: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Mayne Pharma International Pty Ltd.Salisbury South, AustraliaMakes it and tests it Problems found, fixed voluntarilyMar 21, 2025 · 6 inspections
Catalent Greenville, Inc.Greenville, NC, United StatesTests it, packages it and labels it Problems found, fixed voluntarilyOct 24, 2025 · 13 inspections

Product details

Generic drug
Itraconazole: every company that makes it
Form
capsule, gelatin coated, oral
Strength
65 mg
Approval
NDA NDA208901
On the market since
Dec 11, 2018
Package NDCs
51862-462-08 51862-462-60 51862-462-88
Official label
DailyMed (National Library of Medicine), updated Apr 23, 2025

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