2026-12236: SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams
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The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride (HCl) Extended-Release (ER) tablets, 27 milligrams (mg), 36 mg, and 54 mg, held by SpecGx LLC (SpecGx), 385 Marshall Ave., Webster Groves, MO 63119. SpecGx requested withdrawal of approval of this application and has waived its opportunity for a hearing.
The agency’s own summary, as published.
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