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Daptomycin

These highlights do not include all the information needed to use DAPTOMYCIN FOR INJECTION safely and effectively. See full prescribing information for DAPTOMYCIN FOR INJECTION. DAPTOMYCIN for injection, for intravenous use Initial U.S. Approval: 2003

Approved
Approval ID

07bc65c6-f302-4d16-9803-a8567fe76f38

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 4, 2023

Manufacturers
FDA

Camber Pharmaceuticals, Inc.

DUNS: 826774775

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Daptomycin

PRODUCT DETAILS

NDC Product Code31722-215
Application NumberANDA216445
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJanuary 4, 2023
Generic NameDaptomycin

INGREDIENTS (2)

DAPTOMYCINActive
Quantity: 350 mg in 7 mL
Code: NWQ5N31VKK
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

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Daptomycin - FDA Drug Approval Details