Back to signals
Federal RegisterGuidance and regulationPublished June 3, 2026

Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Open the source record
Tags
health IT, Notice, Health and Human Services Department, Food and Drug Administration
Related exam domains
None matched
Source record id
2026-11062
First seen by InfoSec Signals
9/23/2026

Exam domain labels come from a keyword heuristic and are study hints, not an official mapping. The summary is the publisher's own text, shortened; the linked record is authoritative.