Regulatory UpdatesSep 23, 2026•1 min read

FDA Approves Labeling Supplements for Discontinued Divalproex Sodium Delayed‑Release Tablets

By the PharmaCountry team

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.

The FDA’s database for ANDA 076941 lists three oral delayed‑release tablet products containing Divalproex Sodium (product numbers 001, 002, 003). All three are marked as discontinued. Each product contains Divalproex Sodium equivalent to 125 mg, 250 mg, or 500 mg of valproic acid, respectively. The agency recorded multiple supplemental (SUPPL) submissions related to labeling for these products. Submissions numbered 5, 7, 9, 13, 15, 17, 19, 21, 23, and 25 were approved (status “AP”) with labeling class codes. Approval dates include 13 Oct 2020, 13 Sep 2014, and 20 Feb 2016. No reference drug status or reference standard was indicated for any of the products.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #Divalproex Sodium #labeling #generic drug #oral dosage #discontinued