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 two suppliers. 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. Seven 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
Formulation / Manufacturing:	see details

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 AUTHORIZED GENERIC	Teva Parenteral Medicines, Inc.	0703-0125	0703-0125-01	1 VIAL, SINGLE-USE in 1 CARTON (0703-0125-01) > 10 mL in 1 VIAL, SINGLE-USE
CUBICIN RF	daptomycin	POWDER;INTRAVENOUS	021572	NDA AUTHORIZED GENERIC	Teva Parenteral Medicines, Inc.	0703-0125	0703-0125-01	1 VIAL, SINGLE-USE in 1 CARTON (0703-0125-01) > 10 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;IV (INFUSION)			Strength	250MG/VIAL
Approval Date:	Sep 12, 2003	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	500MG/VIAL
Approval Date:	Sep 12, 2003	TE:	AP	RLD:	Yes
Regulatory Exclusivity Expiration:	Mar 29, 2020
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Sep 1, 2020
Regulatory Exclusivity Use:	PROVIDES FOR LABELING CHANGES REGARDING THE USE OF DAPTOMYCIN IN THE PEDIATRIC POPULATION FOR STAPHYLOCOCCUS AUREUS BACTEREMIA (SAB) BASED ON RESULTS OF A TRIAL IN PEDIATRIC PATIENTS 1 TO 17 YEARS OF AGE

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;IV (INFUSION)	021572-001	Sep 12, 2003	➤ Try a Free Trial	➤ Try a Free Trial
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	➤ Try a Free Trial	➤ Try a Free Trial
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;INTRAVENOUS	021572-002	Sep 12, 2003	➤ Try a Free Trial	➤ Try a Free Trial
Cubist Pharms Llc	CUBICIN	daptomycin	POWDER;IV (INFUSION)	021572-001	Sep 12, 2003	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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