Regulatory · source year
7 selected, source-linked regulatory records dated 2006. This is selective source coverage, not a complete timeline.
7 selected records.
5 connected profiles.
7 distinct public records.
Cited chronology
Octreotide
The Federal Register published notice E6-17284, attributed to FDA and its parent HHS department, on 2006-10-18. Its official title is “Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability,” and PeptideScanner's exact reviewed identity mapping connects the document to Octreotide.
Source: Federal Register via GovInfo ↗
Exenatide
The Federal Register published notice E6-16086, attributed to FDA and its parent HHS department, on 2006-10-02. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; BYETTA,” and PeptideScanner's exact reviewed identity mapping connects the document to Exenatide.
Source: Federal Register via GovInfo ↗
Pramlintide
The Federal Register published notice E6-9414, attributed to FDA and its parent HHS department, on 2006-06-16. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; SYMLIN,” and PeptideScanner's exact reviewed identity mapping connects the document to Pramlintide.
Source: Federal Register via GovInfo ↗
Glucagon
The Federal Register published notice E6-9440, attributed to FDA and its parent HHS department, on 2006-06-16. Its official title is “Merck & Co., Inc., et al.; Withdrawal of Approval of 65 New Drug Applications and 52 Abbreviated New Drug Applications,” and PeptideScanner's exact reviewed identity mapping connects the document to Glucagon.
Source: Federal Register via GovInfo ↗
Ziconotide
The Federal Register published notice E6-3712, attributed to FDA and its parent HHS department, on 2006-03-15. Its official title is “Determination of Regulatory Review Period for Purposes of Patent Extension; PRIALT,” and PeptideScanner's exact reviewed identity mapping connects the document to Ziconotide.
Source: Federal Register via GovInfo ↗
Octreotide
The official Drugs@FDA dataset lists original submission 1 for ANDA 077450 with status AP dated 2006-02-10, and names octreotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗
Octreotide
The official Drugs@FDA dataset lists original submission 1 for ANDA 077457 with status AP dated 2006-02-10, and names octreotide acetate among the application record's active ingredients.
Source: Drugs@FDA via openFDA ↗