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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077478

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VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE)
EQ 500MG BASE
Marketing Status: Prescription
Active Ingredient: VALACYCLOVIR HYDROCHLORIDE
Proprietary Name: VALACYCLOVIR HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 500MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077478
Product Number: 001
Approval Date: May 24, 2010
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE)
EQ 1GM BASE
Marketing Status: Prescription
Active Ingredient: VALACYCLOVIR HYDROCHLORIDE
Proprietary Name: VALACYCLOVIR HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 1GM BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077478
Product Number: 002
Approval Date: May 24, 2010
Applicant Holder Full Name: SANDOZ INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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