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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202408

AVACLYR (ACYCLOVIR)
3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ACYCLOVIR
Proprietary Name: AVACLYR
Dosage Form; Route of Administration: OINTMENT; OPHTHALMIC
Strength: 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N202408
Product Number: 001
Approval Date: Mar 29, 2019
Applicant Holder Full Name: FERA PHARMACEUTICALS LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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