The official Drugs@FDA dataset lists original submission 1 for ANDA 075471 with status AP dated 2000-10-25, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 021088 with status AP dated 2000-03-03, and names leuprolide acetate among the application record's active ingredients.
The Federal Register published notice 00-1872, attributed to FDA and its parent HHS department, on 2000-01-27. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; GlucaGen®,” and PeptideScanner's exact reviewed identity mapping connects the document to Glucagon.