Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022257

VALCYTE (VALGANCICLOVIR HYDROCHLORIDE)
50MG/ML Marketing Status: Prescription

Active Ingredient: VALGANCICLOVIR HYDROCHLORIDE
Proprietary Name: VALCYTE
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: 50MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022257
Product Number: 001
Approval Date: Aug 28, 2009
Applicant Holder Full Name: HOFFMANN LA ROCHE INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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