法规动态

FDA、EMA、TGA 及全球法规动态

#valacyclovir ×

2026年8月31日•1 分钟阅读

FDA Approves ANDA077655 for VALACYCLOVIR HYDROCHLORIDE Tablets

FDA has approved ANDA077655 for valacyclovir hydrochloride oral tablets (500 mg and 1 g) from Teva Pharm, with original and supplemental labeling approvals.

2026年8月24日•1 分钟阅读

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.