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Regulatorische Updates

Regulatorische Entwicklungen von FDA, EMA, TGA und weltweit

#Divalproex Sodium ×

UPDATED
Regulatorische Updates
25. Sept. 2026•1 Min. Lesezeit
FDA Approves ANDA078979 for DIVALPROEX SODIUM
The FDA has approved application ANDA078979 for the oral delayed‑release capsule of DIVALPROEX SODIUM, manufactured by NorthStar Rx LLC and Dr. Reddy's Laboratories Ltd.
UPDATED
Regulatorische Updates
23. Sept. 2026•1 Min. Lesezeit
FDA Approves Labeling Supplements for Discontinued Divalproex Sodium Delayed‑Release Tablets
The FDA records show that three discontinued oral delayed‑release tablet products of Divalproex Sodium (125 mg, 250 mg, 500 mg) received approved labeling supplemental submissions.