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Tag: Is azo fda approved

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Is Azo FDA Approved? Unpacking the Complex Regulatory Status

4 min read
Based on regulatory records, the active ingredient in AZO urinary pain relief products, phenazopyridine, is an unapproved drug that has never gone through the full FDA approval process for safety and effectiveness. The question of “Is Azo fda approved?” is complex and reveals a historical quirk in drug regulation.