WASHINGTON, Oct. 6 -- Food and Drug Administration has issued a notice called: Teva Pharmaceuticals USA, Inc, et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications; Correction.
The notice was published in the Federal Register on Oct. 6 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.
Summary: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Registeron May 7, 2026. The document announced the withdrawal of approval of 15 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 8, 2026. The document indicated that FDA was withdrawing approval of ANDA 210285 for dimethyl fumarate delayed-release capsule, 120 mi...