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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

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UPDATED
Regulatorische Updates
25. Sept. 2026•1 Min. Lesezeit
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.
UPDATED
Regulatorische Updates
24. Sept. 2026•1 Min. Lesezeit
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.