APPLICATION
ANDA213786
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-29
LATEST ACTION
2026-01-30
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
DAPTOMYCINPrescription
DAPTOMYCIN 350MG/VIAL · POWDER · INTRAVENOUS
Approval history
2026-01-30Labeling · Supplement 8 · standardAP
2023-03-22Labeling · Supplement 3 · standardAP
2021-06-29UNKNOWN · 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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