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Capecitabine - Generic Drug Details

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Capecitabine is the generic ingredient in two branded drugs marketed by Mylan Pharms Inc, Teva Pharms Usa, Accord Hlthcare, and Hoffmann La Roche, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for capecitabine. Eleven suppliers are listed for this compound.

Summary for Generic Name: capecitabine

Tradenames:2
Patents:0
Applicants:4
NDAs:4
Drug Master File Entries: see list27
Suppliers / Packaging: see list11
Formulation / Manufacturing:see details

Pharmacology for Ingredient: capecitabine

Clinical Trials for: capecitabine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
CAPECITABINE
capecitabine
TABLET;ORAL091649-002Sep 16, 2013RXNo<disabled><disabled>
Accord Hlthcare
CAPECITABINE
capecitabine
TABLET;ORAL202593-002Apr 23, 2015RXNo<disabled><disabled>
Mylan Pharms Inc
CAPECITABINE
capecitabine
TABLET;ORAL090943-001Aug 8, 2014RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: capecitabine

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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;ORAL020896-002Apr 30, 19984,966,891<disabled>
Hoffmann La Roche
XELODA
capecitabine
TABLET;ORAL020896-002Apr 30, 19985,472,949*PED<disabled>
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