Details for New Drug Application (NDA): 021572

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NDA 021572 describes CUBICIN RF, which is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the CUBICIN RF profile page.

The generic ingredient in CUBICIN RF is daptomycin. There are ten drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the daptomycin profile page.

Summary for 021572

Tradename:	CUBICIN RF
Applicant:	Cubist Pharms Llc
Ingredient:	daptomycin
Patents:	2

Pharmacology for NDA: 021572

Medical Subject Heading (MeSH) Categories for 021572

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 021572

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572	NDA	Merck Sharp & Dohme LLC	67919-012	67919-012-01	1 VIAL, SINGLE-USE in 1 CARTON (67919-012-01) / 10 mL in 1 VIAL, SINGLE-USE
CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572	NDA	Merck Sharp & Dohme LLC	67919-012	67919-012-01	1 VIAL, SINGLE-USE in 1 CARTON (67919-012-01) / 10 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 12, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 12, 2003	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Sep 4, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 6, 2016	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Nov 23, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021572

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003	⤷ Sign Up	⤷ Sign Up
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003	⤷ Sign Up	⤷ Sign Up
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-001	Sep 12, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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