Business · 18/06/20261 min read

FDA Withdraws Approval of Methylphenidate Hydrochloride Extended-Release Tablets ANDA

The US Food and Drug Administration (FDA) has withdrawn its approval of an abbreviated new drug application (ANDA) for Methylphenidate Hydrochloride Extended-Release tablets in three strengths, following a request from SpecGx LLC, which waived its right to a hearing. SpecGx LLC is based at 385 Marshall Ave., Webster Groves, MO 63119.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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