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FDA NDA · NDA217415

DAPTOMYCIN

Sponsor: HIKMA

APPLICATION
NDA217415
TYPE
NDA
ORIGINAL APPROVAL
2023-01-30
LATEST ACTION
2025-04-30
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

DAPTOMYCIN · ReferencePrescription
DAPTOMYCIN 500MG/VIAL · POWDER · INTRAVENOUS
DAPTOMYCIN · ReferencePrescription
DAPTOMYCIN 350MG/VIAL · POWDER · INTRAVENOUS

Approval history

2025-04-30Labeling · Supplement 4 · standard — Letter ↗AP
2025-02-05Labeling · Supplement 3 · standard — Letter ↗AP
2023-01-30Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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