2 selected, source-linked Leuprolide records carrying a 1998 source date. This is a navigational view of PeptideScanner’s selected coverage—not a complete research timeline or a statement about safety or effectiveness.
The official Drugs@FDA dataset lists original submission 1 for ANDA 074728 with status AP dated 1998-08-04, and names leuprolide acetate among the application record's active ingredients.
The Federal Register published notice 98-13045, attributed to FDA and its parent HHS department, on 1998-05-18. Its official title is “Environmental Assessments and Findings of No Significant Impact,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.