APPLICATION
ANDA091039
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-25
LATEST ACTION
2019-11-12
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
DAPTOMYCINPrescription
DAPTOMYCIN 500MG/VIAL · POWDER · INTRAVENOUS
Approval history
2019-11-12Labeling · Supplement 4 · standardAP
2019-11-12Labeling · Supplement 2 · standardAP
2019-11-12Labeling · Supplement 3 · standardAP
2016-12-21Labeling · Supplement 1 · standardAP
2016-03-25OriginalAP
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.