APPLICATION
ANDA205037
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-05
LATEST ACTION
2025-04-09
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
DAPTOMYCINPrescription
DAPTOMYCIN 500MG/VIAL · POWDER · INTRAVENOUS
Approval history
2025-04-09Labeling · Supplement 9 · standardAP
2025-04-09Labeling · Supplement 7 · standardAP
2025-04-09Labeling · Supplement 6 · standardAP
2025-04-09Labeling · Supplement 11 · standardAP
2018-06-05UNKNOWN · Original · standardAP
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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