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They do not constitute FDA approval or a final Agency decision but will inform the FDAs broader evaluation of whether each substance should be included on the 503A Bulks List
It can be provided either with an IV drip or through an intramuscular injection
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No regulatory body Health Canada, the FDA, the EMA, the TGA, or any equivalent has approved either component compound, or the blend formulation, as a drug for human or veterinary use
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