← FDA DRUG APPROVALS

FDA NDA · NDA204684

IMPAVIDO

miltefosine

Sponsor: KNIGHT THERAPS

APPLICATION
NDA204684
TYPE
NDA
ORIGINAL APPROVAL
2014-03-19
LATEST ACTION
2025-03-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

IMPAVIDO · ReferencePrescription
MILTEFOSINE 50MG · CAPSULE · ORAL

Approval history

2025-03-14Labeling · Supplement 7 · standard — Label ↗AP
2025-03-14Labeling · Supplement 8 · standard — Label ↗AP
2021-05-25Labeling · Supplement 6 · standard — Letter ↗AP
2016-01-04Manufacturing (CMC) · Supplement 3 · priorityAP
2015-11-04Manufacturing (CMC) · Supplement 2 · priorityAP
2015-04-10Manufacturing (CMC) · Supplement 1 · priorityAP
2014-03-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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