FDA ANDA · ANDA206077
DAPTOMYCIN
Sponsor: FRESENIUS KABI USA
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APPLICATION
ANDA206077
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-11
LATEST ACTION
2026-10-14
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
DAPTOMYCINPrescription
DAPTOMYCIN 500MG/VIAL · POWDER · INTRAVENOUS
Approval history
2026-10-14Labeling · Supplement 10 · standardAP
2023-05-16Labeling · Supplement 9 · standardAP
2023-05-16Labeling · Supplement 6 · standardAP
2023-05-16Labeling · Supplement 4 · standardAP
2018-04-11UNKNOWN · Original · standardAP
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