法规动态

FDA、EMA、TGA 及全球法规动态

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2026年9月22日•1 分钟阅读

FDA Approves Buprenorphine ANDA078633 Sublingual Tablets

FDA has approved an ANDA for buprenorphine sublingual tablets (2 mg and 8 mg) from Hikma Pharmaceuticals USA Inc., with associated labeling and REMS submissions.