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XELODA Drug Profile

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Xeloda is a drug marketed by Hoffmann La Roche and is included in one NDA. It is available from three suppliers.

The generic ingredient in XELODA is capecitabine. There are twenty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the capecitabine profile page.

Summary for Tradename: XELODA

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: XELODA

Clinical Trials for: XELODA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-001Apr 30, 1998RXNo<disabled><disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 1998RXYes<disabled><disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-001Apr 30, 1998RXNo<disabled><disabled>
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Expired Patents for Tradename: XELODA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-001Apr 30, 19984,966,891<disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-001Apr 30, 19985,472,949*PED<disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 19984,966,891<disabled>
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Paragraph IV activity for: XELODA

Drugname Dosage Strength RLD Submissiondate
capecitabineTablets150 mg and 500 mgXeloda11/10/2008
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