Regulatory Updates
Sep 25, 2026•1 min read
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.
Regulatory Updates
Sep 23, 2026•1 min read
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.