APPLICATION
ANDA207104
TYPE
ANDA
ORIGINAL APPROVAL
2019-11-15
LATEST ACTION
2023-09-19
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
DAPTOMYCINPrescription
DAPTOMYCIN 500MG/VIAL · POWDER · INTRAVENOUS
Approval history
2023-09-19Labeling · Supplement 7 · standardAP
2023-09-19Labeling · Supplement 5 · standardAP
2023-09-19Labeling · Supplement 3 · standardAP
2023-09-19Labeling · Supplement 6 · standardAP
2019-11-15UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.