The Federal Register published notice 2024-08657, attributed to FDA and its parent HHS department, on 2024-04-23. Its official title is “PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide. 1
This page reports bounded metadata from a Federal Register document attributed to FDA and its parent HHS department, and links to the official GovInfo PDF. It does not interpret legal effect, approval, safety, effectiveness, compounding status, or medical use. 1
What this source can tell us. PeptideScanner is reporting the cited regulator or label record. The summary does not extend that record into broader safety, effectiveness, or approval claims.