← FDA DRUG APPROVALS

FDA NDA · NDA208901

TOLSURA

itraconazole

Sponsor: MAYNE PHARMA

APPLICATION
NDA208901
TYPE
NDA
ORIGINAL APPROVAL
2018-12-11
LATEST ACTION
2024-10-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

TOLSURA · ReferencePrescription
ITRACONAZOLE 65MG · CAPSULE · ORAL

Approval history

2024-10-25Labeling · Supplement 4 · standardLabelAP
2018-12-11Type 5 - New Formulation or New Manufacturer · Original · standardLabelAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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