Regulatory UpdatesAug 24, 2026•1 min read

FDA Approves ANDA078070 for Valacyclovir Hydrochloride Tablets by Pharmobedient

By the PharmaCountry team

The FDA approved application ANDA078070 submitted by Pharmobedient for oral valacyclovir hydrochloride tablets (500 mg and 1 g equivalents). Both products are listed as discontinued.

The U.S. Food and Drug Administration has granted approval for application number ANDA078070, submitted by Pharmobedient. The approval covers two oral tablet products of valacyclovir hydrochloride, identified as product numbers 001 and 002. Product 001 is a 500 mg equivalent tablet, and product 002 is a 1 g equivalent tablet. Both products are listed with a marketing status of “Discontinued.” The submission was an original (ORIG) filing, received approval status (AP) on May 24, 2010.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#valacyclovir #ANDA #FDA approval #oral tablets #Pharmobedient #discontinued