FDA withdraws approval of 37 ANDAs
The agency is withdrawing approval of 37 abbreviated new drug applications from multiple applicants. The applicants notified the FDA that the drug products were no longer marketed and requested the approvals be withdrawn.
Primary source
Federal Register notice, October 9, 2026
Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications
Read the source: Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications federalregister.gov
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