Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#carvedilol ×
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
25 sept 2026•1 min de lectura
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.
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Actualizaciones regulatorias
18 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
10 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
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.
Actualizaciones regulatorias
23 ago 2026•1 min de lectura
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.
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