Details for New Drug Application (NDA): 021673

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NDA 021673 describes CLOLAR, which is a drug marketed by Genzyme and is included in one NDA. It is available from two suppliers. Additional details are available on the CLOLAR profile page.

The generic ingredient in CLOLAR is clofarabine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the clofarabine profile page.

Summary for 021673

Tradename:	CLOLAR
Applicant:	Genzyme
Ingredient:	clofarabine
Patents:	0

Pharmacology for NDA: 021673

Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Suppliers and Packaging for NDA: 021673

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673	NDA	Sanofi-Aventis U.S. LLC	0024-5860	0024-5860-01	1 VIAL, SINGLE-USE in 1 BOX (0024-5860-01) / 20 mL in 1 VIAL, SINGLE-USE
CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673	NDA AUTHORIZED GENERIC	Winthrop U.S, a business of sanofi-aventis U.S. LLC	0955-1746	0955-1746-01	1 VIAL, SINGLE-USE in 1 BOX (0955-1746-01) / 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	20MG/20ML (1MG/ML)
Approval Date:	Dec 28, 2004	TE:	AP	RLD:	Yes

Expired US Patents for NDA 021673

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	⤷ Sign Up	⤷ Sign Up
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	⤷ Sign Up	⤷ Sign Up
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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