The official Drugs@FDA dataset lists original submission 1 for NDA 021008 with status AP dated 1998-11-25, and names octreotide acetate among the application record's active ingredients.
The Federal Register published proposed rule 98-29855, attributed to FDA and its parent HHS department, on 1998-11-12. Its official title is “Medical Devices; Exemption From Premarket Notification and Reserved Devices; Class I,” and PeptideScanner's exact reviewed identity mapping connects the document to Glucagon.
The official Drugs@FDA dataset lists original submission 1 for NDA 020928 with status AP dated 1998-09-11, and names glucagon among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for ANDA 074728 with status AP dated 1998-08-04, and names leuprolide acetate among the application record's active ingredients.
The official Drugs@FDA dataset lists original submission 1 for NDA 020918 with status AP dated 1998-06-22, and names glucagon hydrochloride among the application record's active ingredients.
The Federal Register published notice 98-13045, attributed to FDA and its parent HHS department, on 1998-05-18. Its official title is “Environmental Assessments and Findings of No Significant Impact,” and PeptideScanner's exact reviewed identity mapping connects the document to Leuprolide.
The Federal Register published notice 98-2498, attributed to FDA and its parent HHS department, on 1998-02-02. Its official title is “Medical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I,” and PeptideScanner's exact reviewed identity mapping connects the document to Glucagon.