APPLICATION
ANDA215316
TYPE
ANDA
ORIGINAL APPROVAL
2021-08-24
LATEST ACTION
2022-11-13
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
DAPTOMYCINPrescription
DAPTOMYCIN 500MG/VIAL · POWDER · INTRAVENOUS
Approval history
2022-11-13Labeling · Supplement 2 · standardAP
2022-11-13Labeling · Supplement 1 · standardAP
2021-08-24UNKNOWN · 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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