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FDA NDA · NDA213464

LAMPIT

nifurtimox

Sponsor: BAYER HEALTHCARE

APPLICATION
NDA213464
TYPE
NDA
ORIGINAL APPROVAL
2020-08-06
LATEST ACTION
2023-06-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LAMPIT · ReferencePrescription
NIFURTIMOX 120MG · TABLET · ORAL
LAMPIT · ReferencePrescription
NIFURTIMOX 30MG · TABLET · ORAL

Approval history

2023-06-02Efficacy · Supplement 5 · standard — Letter ↗AP
2023-02-22Labeling · Supplement 4 · standard — Letter ↗AP
2022-01-27Labeling · Supplement 3 · standard — Label ↗AP
2020-10-02Labeling · Supplement 1 · standard — Letter ↗AP
2020-08-06Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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