Business · 19/04/2022Updated: 10/17/2026 · 1 min read

Fresenius Kabi USA, LLC, et al. Withdrawal of FDA Approval for Five Abbreviated New Drug Applications

Summary

The FDA is correcting a notice regarding the withdrawal of approval for five abbreviated new drug applications, including ANDA 091008 for Gabapentin Capsules, following a request from Jiangsu Hengrui Pharmaceuticals Co., Ltd. to preserve the approval.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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