American Critical Care's naloxone HCl
FDA said 1 mg/ml injectable naloxone to be packaged in 5 ml and 10 ml (5 mg and 10 mg total drug content, respectively) multiple dose vials is suitable for ANDA submissions. The ANDAs involve a change in total drug strength from the listed drug, DuPont's Narcane, from 2 mg to 5 mg or 10 mg.
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