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How Tylenol Elixir Became an “Exceptionally Safe” Pain and Fever Reliever for Children (NDA 009927)
By Dr. Donald Fox When you pick up a bottle of children’s acetaminophen today, it’s easy to forget that this medicine had to prove itself—slowly, carefully, and in writing—to the U.S. government. What you shared is a fascinating paper trail: internal FDA correspondence, clinical notes, and the 1972 Federal Register notice that all orbit around NDA 009927 —McNeil Laboratories’ 1955 New Drug Application for Tylenol Elixir (N-acetyl-p-aminophenol, later known to everyone as ace

The Chairman
10 hours ago4 min read
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