The Federal Register published notice E8-27179, attributed to FDA and its parent HHS department, on 2008-11-17. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT,” and PeptideScanner's exact reviewed identity mapping connects the document to Lanreotide.
The Federal Register published notice E8-24356, attributed to FDA and its parent HHS department, on 2008-10-15. Its official title is “Pediatric Advisory Committee; Notice of Meeting,” and PeptideScanner's exact reviewed identity mapping connects the document to Octreotide.
The official Drugs@FDA dataset lists original submission 1 for ANDA 077329 with status AP dated 2008-03-04, and names octreotide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 077330 with status AP dated 2008-03-04, and names octreotide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 077331 with status AP dated 2008-03-04, and names octreotide acetate among the application record's active ingredients.