Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020487

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VALTREX (VALACYCLOVIR HYDROCHLORIDE)
EQ 500MG BASE
Marketing Status: Prescription
Active Ingredient: VALACYCLOVIR HYDROCHLORIDE
Proprietary Name: VALTREX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N020487
Product Number: 001
Approval Date: Jun 23, 1995
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information
VALTREX (VALACYCLOVIR HYDROCHLORIDE)
EQ 1GM BASE
Marketing Status: Prescription
Active Ingredient: VALACYCLOVIR HYDROCHLORIDE
Proprietary Name: VALTREX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1GM BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020487
Product Number: 002
Approval Date: Jun 23, 1995
Applicant Holder Full Name: GLAXOSMITHKLINE
Marketing Status:  Prescription
Patent and Exclusivity Information

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