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Last Updated: May 23, 2024

Details for New Drug Application (NDA): 202408


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NDA 202408 describes AVACLYR, which is a drug marketed by Fera Pharms Llc and is included in one NDA. Additional details are available on the AVACLYR profile page.

The generic ingredient in AVACLYR is acyclovir. There are fifty-six drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the acyclovir profile page.
Summary for 202408
Tradename:AVACLYR
Applicant:Fera Pharms Llc
Ingredient:acyclovir
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202408

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:OINTMENT;OPHTHALMICStrength3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Mar 29, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 29, 2026
Regulatory Exclusivity Use:INDICATED FOR THE TREATMENT OF ACUTE HERPETIC KERATITIS (DENDRITIC ULCERS) IN PATIENTS WITH HERPES SIMPLEX (HSV-1 AND HSV-2) VIRUS

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