FDA approves labeling supplement for Zydus gabapentin ANDA
The FDA approved a labeling-related supplement for Zydus Pharmaceuticals' generic gabapentin tablets on July 17, 2026.
This week's update covers a single regulatory action for Zydus Pharmaceuticals' generic gabapentin.
- Gabapentin tablets, an oral generic drug marketed by Zydus Pharms under ANDA203934, received FDA approval for a labeling supplement (submission number 4) with a status date of 2026-07-17. The approval covers oral tablet formulations in strengths of 900MG, 450MG, 300MG, 750MG, and 600MG.1
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