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).
規制動向2026年9月25日•1分で読めます
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.
PharmaCountryチームがまとめました · 出典： FDA.gov
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