ACTIVE SUBSTANCE / INN

DAPTOMYCIN

Brand name(s): CUBICIN RF, DAPTOMYCIN, Cubicin, DAPZURA RT, DAPTOMYCIN IN 0.9% SODIUM CHLORIDE, CUBICIN, Daptomycin Hospira

FDA LISTED

EMA LISTED

PRESCRIPTION

DISCONTINUED

AUTHORISED

NDA213645

ANDA212022

ACTIVE SUBSTANCE

Daptomycin

REGULATORS

FDA · EMA

SPONSORS / MAH

BAXTER HLTHCARE CORP, HENGRUI PHARMA, CUBIST PHARMS LLC

TOTAL APPLICATIONS

FDA APPLICATIONS (DRUGS@FDA)

BRAND NAME	APPLICATION	SPONSOR	STATUS
DAPTOMYCIN	ANDA206005	XELLIA PHARMS APS	Prescription
DAPTOMYCIN	ANDA212022	HENGRUI PHARMA	Discontinued
CUBICIN	NDA021572	CUBIST PHARMS LLC	Discontinued
CUBICIN RF	NDA021572	CUBIST PHARMS LLC	Discontinued
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE	NDA213645	BAXTER HLTHCARE CORP	Prescription
DAPZURA RT	NDA213645	BAXTER HLTHCARE CORP	Discontinued
DAPTOMYCIN	NDA203797	HOSPIRA INC	None (Tentative Approval)

EMA AUTHORISATIONS

PRODUCT NAME	HOLDER	STATUS	DATE	INDICATION
Daptomycin Hospira	Pfizer Europe MA EEIG	Authorised	22/03/2017	Soft Tissue Infections;Skin Diseases, Bacterial
Cubicin	Merck Sharp & Dohme B.V.	Authorised	19/01/2006	Gram-Positive Bacterial Infections;Bacteremia;Soft Tissue Infections;Endocarditi…

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