APPLICATION
ANDA206005
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-15
LATEST ACTION
2020-09-09
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
DAPTOMYCINPrescription
DAPTOMYCIN 500MG/VIAL · POWDER · INTRAVENOUS
Approval history
2020-09-09Labeling · Supplement 19 · standardAP
2020-09-09Labeling · Supplement 17 · standardAP
2019-10-03Labeling · Supplement 14 · standardAP
2019-10-03Labeling · Supplement 6 · standardAP
2019-10-03Labeling · Supplement 11 · standardAP
2016-12-21Labeling · Supplement 1 · standardAP
2016-06-15UNKNOWN · 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.
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