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Generated: November 15, 2018

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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 one supplier. There is one patent protecting this drug and one Paragraph IV challenge. 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. Seven 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:1
Pharmacology for NDA: 021673
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 sanofi-aventis U.S. LLC 0024-5917 0024-5917-01 1 VIAL, SINGLE-USE in 1 BOX (0024-5917-01) > 20 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength20MG/20ML (1MG/ML)
Approval Date:Dec 28, 2004TE:APRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 14, 2018Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021673

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Genzyme CLOLAR clofarabine SOLUTION;INTRAVENOUS 021673-001 Dec 28, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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