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Aquarium Pharmacy LLC distributed unapproved antimicrobial drugs intended for aquarium fish, including amoxicillin, azithromycin, ciprofloxacin, and other medically important antibiotics, without FDA approval or proper drug listing. The products violated federal law by being misbranded—they were not listed with FDA and were not manufactured in FDA-registered facilities as required. The company's website contained therapeutic claims establishing these products were intended to treat, cure, or prevent diseases in animals, thereby defining them as new animal drugs that required premarket approval before distribution.