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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050759

CELLCEPT (MYCOPHENOLATE MOFETIL)
200MG/ML
Marketing Status: Prescription
Active Ingredient: MYCOPHENOLATE MOFETIL
Proprietary Name: CELLCEPT
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: 200MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N050759
Product Number: 001
Approval Date: Oct 1, 1998
Applicant Holder Full Name: ROCHE PALO ALTO LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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