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FDA NDA · NDA214155

KIMYRSA

oritavancin diphosphate

Sponsor: MELINTA THERAP

APPLICATION
NDA214155
TYPE
NDA
ORIGINAL APPROVAL
2021-03-12
LATEST ACTION
2025-04-24
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

KIMYRSA · ReferencePrescription
ORITAVANCIN DIPHOSPHATE EQ 1.2GM BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2025-04-24Labeling · Supplement 5 · standard — Label ↗AP
2021-07-23Labeling · Supplement 1 · standard — Label ↗AP
2021-03-12Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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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