法规动态

FDA、EMA、TGA 及全球法规动态

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2026年9月25日•1 分钟阅读

FDA Approves DIVALPROEX SODIUM (ANDA078853)

FDA grants approval for DIVALPROEX SODIUM tablets (ANDA078853) by Bionpharma Inc., with oral delayed‑release 125 mg, 250 mg and 500 mg equivalents.

2026年9月24日•1 分钟阅读

FDA Approves Bionpharma’s Nicardipine Hydrochloride Capsules (ANDA217555)

The FDA granted approval (AP) for Bionpharma Inc.’s nicardipine hydrochloride oral capsules, 20 mg and 30 mg strengths, under application ANDA217555.