Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 7, 2019

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 one supplier. 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. Twenty-one 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)
Paragraph IV (Patent) Challenges for 020896
Tradename Dosage Ingredient NDA Submissiondate
XELODA TABLET;ORAL capecitabine 020896 2008-11-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Apr 30, 1998TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Apr 30, 1998TE:ABRLD:Yes

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

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