The Federal Register published notice 2011-14164, attributed to FDA and its parent HHS department, on 2011-06-08. Its official title is “Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The official Drugs@FDA dataset lists original submission 1 for ANDA 090985 with status AP dated 2011-05-11, and names octreotide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 090986 with status AP dated 2011-05-11, and names octreotide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 079198 with status AP dated 2011-02-10, and names octreotide acetate among the application record's active ingredients.