The U.S. Food and Drug Administration has issued an approval (status AP) for ANDA076877, an abbreviated new drug application submitted by Senores Pharms. The application covers two oral tablet products containing gabapentin at strengths of 600 mg and 800 mg.
Both products are currently marked as discontinued in the FDA database. The original submission (submission number 1) received approval on July 6, 2006, and a labeling supplement (submission number 4) was approved on September 24, 2014.
法规动态2026年8月24日•1 分钟阅读
FDA Approves ANDA076877 for Gabapentin Tablets (Discontinued)
FDA approved ANDA076877 for gabapentin 600mg and 800mg oral tablets submitted by Senores Pharms; both products are listed as discontinued.
由 PharmaCountry 团队整理 · 来源： FDA.gov
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