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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021304

VALCYTE (VALGANCICLOVIR HYDROCHLORIDE)
EQ 450MG BASE
Marketing Status: Prescription
Active Ingredient: VALGANCICLOVIR HYDROCHLORIDE
Proprietary Name: VALCYTE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 450MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021304
Product Number: 001
Approval Date: Mar 29, 2001
Applicant Holder Full Name: CHEPLAPHARM ARZNEIMITTEL GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
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