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FDA NDA · NDA213645

DAPTOMYCIN IN SODIUM CHLORIDE

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
NDA213645
TYPE
NDA
ORIGINAL APPROVAL
2022-01-25
LATEST ACTION
2025-04-30
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION, POWDER
MARKETING STATUS
Prescription, Discontinued

Products

DAPTOMYCIN IN 0.9% SODIUM CHLORIDE · ReferencePrescription
DAPTOMYCIN 700MG/100ML (7MG/ML) · SOLUTION · INTRAVENOUS
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE · ReferencePrescription
DAPTOMYCIN 350MG/50ML (7MG/ML) · SOLUTION · INTRAVENOUS
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE · ReferencePrescription
DAPTOMYCIN 1GM/100ML (10MG/ML) · SOLUTION · INTRAVENOUS
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE · ReferencePrescription
DAPTOMYCIN 500MG/50ML (10MG/ML) · SOLUTION · INTRAVENOUS
DAPZURA RT · ReferenceDiscontinued
DAPTOMYCIN 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · POWDER · INTRAVENOUS

Approval history

2025-04-30Labeling · Supplement 6 · standard — Letter ↗AP
2023-02-27Efficacy · Supplement 1 · standard — Label ↗AP
2022-01-25Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
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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