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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 two suppliers. 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. Two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the clofarabine profile page.

Summary for NDA: 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
INJECTABLE;IV (INFUSION) 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
INJECTABLE;IV (INFUSION) 021673 NDA Genzyme Corporation 58468-0100 58468-0100-1 1 VIAL, SINGLE-USE in 1 CARTON (58468-0100-1) > 20 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength20MG/20ML (1MG/ML)
Approval Date:Dec 28, 2004TE:RLD:Yes
Patent:5,661,136*PEDPatent Expiration:Jul 14, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021673

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme
CLOLAR
clofarabine
INJECTABLE;IV (INFUSION)021673-001Dec 28, 20044,918,179► subscribe
Genzyme
CLOLAR
clofarabine
INJECTABLE;IV (INFUSION)021673-001Dec 28, 20045,384,310► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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