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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020896

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XELODA (CAPECITABINE)
150MG
Marketing Status: Prescription
Active Ingredient: CAPECITABINE
Proprietary Name: XELODA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020896
Product Number: 001
Approval Date: Apr 30, 1998
Applicant Holder Full Name: CHEPLAPHARM ARZNEIMITTEL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
XELODA (CAPECITABINE)
500MG
Marketing Status: Prescription
Active Ingredient: CAPECITABINE
Proprietary Name: XELODA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020896
Product Number: 002
Approval Date: Apr 30, 1998
Applicant Holder Full Name: CHEPLAPHARM ARZNEIMITTEL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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