Regulatory UpdatesSep 25, 2026•1 min read

FDA Approves DIVALPROEX SODIUM (ANDA078853)

By the PharmaCountry team

FDA grants approval for DIVALPROEX SODIUM tablets (ANDA078853) by Bionpharma Inc., with oral delayed‑release 125 mg, 250 mg and 500 mg equivalents.

The U.S. Food and Drug Administration has granted approval for the Abbreviated New Drug Application (ANDA) 078853 for DIVALPROEX SODIUM, manufactured by Bionpharma Inc. The approved product is an oral, delayed‑release tablet available in three strengths: 125 mg, 250 mg and 500 mg equivalents of valproic acid. All formulations are prescription‑only. Labeling submissions for this ANDA have been approved on March 18 2014 (submission 6), January 7 2022 (submissions 9, 11, 13) and November 22 2023 (submissions 15, 17).

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#DIVALPROEX #ANDA #FDA #Bionpharma #prescription #Oral