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 Glenmark’s Carvedilol Generic Tablets (ANDA078251)

The FDA has granted labeling approval for Glenmark Pharmaceuticals’ generic carvedilol tablets (ANDA078251), available in 3.125 mg, 6.25 mg, 12.5 mg and 25 mg oral dosage forms.

2026年9月25日•1 分钟阅读

FDA Approves ANDA 077780 for Carvedilol Tablets by TARO

FDA issued an approval letter for ANDA 077780 covering carvedilol oral tablets (3.125 mg, 6.25 mg, 12.5 mg, 25 mg) submitted by TARO; all listed products are marked discontinued.

2026年9月18日•1 分钟阅读

FDA Approves Carvedilol Generic (ANDA 076649) by Dr. Reddy's Laboratories

FDA granted approval for ANDA 076649, a carvedilol oral tablet generic from Dr. Reddy's Laboratories, covering four strengths and prescription use.

2026年9月10日•1 分钟阅读

FDA Approves ANDA078384 for Carvedilol Tablets by Unichem Pharmaceuticals

The FDA has approved ANDA078384 for carvedilol oral tablets (3.125‑25 mg) manufactured by Unichem Pharmaceuticals and sponsored by Regcon Holdings.

2026年8月30日•1 分钟阅读

FDA Approves Teva Generic Carvedilol Tablets (ANDA 076373)

The FDA has granted approval for Teva Pharmaceuticals' generic carvedilol oral tablets, covering strengths from 3.125 mg to 25 mg under ANDA 076373.

2026年8月23日•1 分钟阅读

Label Mixup Recall: Potential Mislabeling of Famotidine 20 mg Tablets

The FDA reports a labeling mixup where Famotidine 20 mg tablets may be mislabeled as Carvedilol Phosphate ER capsules, along with other products.