ReignCorp
Official government records, as published. No commentary. Every entry links to its source.
Agencies › Federal Register document
2026-06-18 · Notice · Federal Register document 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

Health and Human Services Department, Food and Drug Administration

Official abstract: 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.

Read the full document on FederalRegister.gov →Official PDF →
More from Health and Human Services Department →More from Food and Drug Administration →All federal records →