Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

From Federal Register — all agencies (federalregister.gov). First seen Oct 10, 2026.

Sign in to keep notes on this rule, private or shared with your team.