法规动态

FDA、EMA、TGA 及全球法规动态

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2026年9月9日•1 分钟阅读

FOSPHENYTOIN SODIUM (ANDA078736) FDA Approval

FDA approves the original ANDA and multiple labeling supplements for fosphenytoin sodium injection (product 001) by Pharmobedient.

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.