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Federal RegisterGuidance and regulationPublished Jun 3, 2026
Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications
Updated 1 hour ago ()
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
- 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
- Sep 23, 2026
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