WASHINGTON, March 26 -- Food and Drug Administration has issued a notice called: Elite Laboratories, Inc, et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications; Correction.
The notice was published in the Federal Register on March 26 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 September 24, 2025 (90 FR 183), appearing on page 45942 in FR Doc. 2025-18453. The document announced the withdrawal of approval of 72 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of October 23, 2025. The document indicated that FDA was withdrawing approval ...