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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209365

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CAPECITABINE (CAPECITABINE)
150MG
Marketing Status: Prescription
Active Ingredient: CAPECITABINE
Proprietary Name: CAPECITABINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209365
Product Number: 001
Approval Date: Jul 2, 2018
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
CAPECITABINE (CAPECITABINE)
500MG
Marketing Status: Prescription
Active Ingredient: CAPECITABINE
Proprietary Name: CAPECITABINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A209365
Product Number: 002
Approval Date: Jul 2, 2018
Applicant Holder Full Name: MSN LABORATORIES PRIVATE LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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