U.S. FDA Requirements: Tenofovir Disoproxil Fumarate
Pharmaceutical / Drug Definition :
Inhibits activity of HIV by competing with natural substrate deoxyadenosine 5'-triphosphate; disrupts cellular DNA by causing chain termination
In the United States, Tenofovir Disoproxil Fumarate is regulated by the U.S. Food and Drug Administration (FDA). FDA has specific requirements regarding the registration and listing of Tenofovir Disoproxil Fumarate.
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U.S. FDA Regulations:
U.S. FDA Regulation: 21 C.F.R. Part 207
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