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.
規制動向2026年8月24日•1分で読めます
FDA Approves ANDA078070 for Valacyclovir Hydrochloride Tablets by Pharmobedient
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.
PharmaCountryチームがまとめました · 出典： FDA.gov
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