Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203791

Marketing Status: Prescription
Active Ingredient: ACYCLOVIR
Proprietary Name: SITAVIG
Dosage Form; Route of Administration: TABLET; BUCCAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203791
Product Number: 001
Approval Date: Apr 12, 2013
Applicant Holder Full Name: EPI HEALTH LLC
Marketing Status:  Prescription
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