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FDA ANDA · ANDA213623

DAPTOMYCIN

Sponsor: MEITHEAL

APPLICATION
ANDA213623
TYPE
ANDA
ORIGINAL APPROVAL
2021-06-29
LATEST ACTION
2026-03-13
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

DAPTOMYCINPrescription
DAPTOMYCIN 500MG/VIAL · POWDER · INTRAVENOUS

Approval history

2026-03-13Labeling · Supplement 11 · standardAP
2022-11-13Labeling · Supplement 3 · standardAP
2022-11-13Labeling · Supplement 2 · standardAP
2021-06-29UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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