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FDA NDA · NDA211673

XENLETA

lefamulin acetate

Sponsor: HONG KONG

APPLICATION
NDA211673
TYPE
NDA
ORIGINAL APPROVAL
2019-08-19
LATEST ACTION
2021-03-16
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

XENLETA · ReferencePrescription
LEFAMULIN ACETATE EQ 150MG BASE/15ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2021-03-16Labeling · Supplement 2 · standard — Letter ↗AP
2020-10-08Labeling · Supplement 1 · standard — Letter ↗AP
2019-08-19Type 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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