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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Covington
Dow
Colorcon
Citi
Cantor Fitzgerald
Queensland Health
McKinsey
Baxter
UBS

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020896

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NDA 020896 describes XELODA, which is a drug marketed by Hoffmann La Roche and is included in one NDA. It is available from three suppliers. Additional details are available on the XELODA profile page.

The generic ingredient in XELODA is capecitabine. There are twenty-eight drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the capecitabine profile page.
Summary for 020896
Tradename:XELODA
Applicant:Hoffmann La Roche
Ingredient:capecitabine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020896
Medical Subject Heading (MeSH) Categories for 020896
Suppliers and Packaging for NDA: 020896
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XELODA capecitabine TABLET;ORAL 020896 NDA Genentech, Inc. 0004-1100 0004-1100-20 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1100-20)
XELODA capecitabine TABLET;ORAL 020896 NDA Genentech, Inc. 0004-1101 0004-1101-50 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-1101-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Apr 30, 1998TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Dec 10, 2016
Regulatory Exclusivity Use:INFORMATION FROM STUDIES CONDUCTED IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED NON-DISSEMINATED DIFFUSED INTRINSIC BRAINSTEM GLIOMAS
Regulatory Exclusivity Expiration:Jun 10, 2017
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 30, 1998TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Dec 10, 2016
Regulatory Exclusivity Use:INFORMATION FROM STUDIES CONDUCTED IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED NON-DISSEMINATED DIFFUSED INTRINSIC BRAINSTEM GLIOMAS

Expired US Patents for NDA 020896

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998 ➤ Subscribe ➤ Subscribe
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998 ➤ Subscribe ➤ Subscribe
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-001 Apr 30, 1998 ➤ Subscribe ➤ Subscribe
Hoffmann La Roche XELODA capecitabine TABLET;ORAL 020896-002 Apr 30, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

US Army
Novartis
Teva
Federal Trade Commission
Fish and Richardson
McKinsey
Merck
McKesson
Chubb

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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