The official Drugs@FDA dataset lists original submission 1 for ANDA 075959 with status AP dated 2005-11-21, and names octreotide acetate among the application record's active ingredients.
The Federal Register published notice 05-20301, attributed to FDA and its parent HHS department, on 2005-10-07. Its official title is “Solicitation of Public Review and Comment on Research Protocol: Gonadotropin-releasing Hormone Agonist Test in Disorders of Puberty,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 05-20302, attributed to FDA and its parent HHS department, on 2005-10-07. Its official title is “Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The official Drugs@FDA dataset lists original submission 1 for ANDA 075957 with status AP dated 2005-10-03, and names octreotide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 021773 with status AP dated 2005-04-28, and names exenatide synthetic among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 076330 with status AP dated 2005-04-08, and names octreotide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 076313 with status AP dated 2005-03-28, and names octreotide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 021332 with status AP dated 2005-03-16, and names pramlintide acetate among the application record's active ingredients.