The official Drugs@FDA dataset lists original submission 1 for NDA 022074 with status AP dated 2007-08-30, and names lanreotide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 077372 with status AP dated 2007-08-14, and names octreotide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 077373 with status AP dated 2007-08-14, and names octreotide acetate among the application record's active ingredients.
The Federal Register published notice E7-4877, attributed to FDA and its parent HHS department, on 2007-03-19. Its official title is “Pediatric Advisory Committee; Notice of Meeting,” and PeptideScanner's exact reviewed identity mapping connects the document to Octreotide.