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Description
In its complete response letter (CRL), the FDA cited several CMC issues, open observations from pre-approval manufacturing inspections and a lack of substantial evidence, according to Outlook

[DOI] [PubMed] [Google Scholar] 447.Collado Camps E, et al

The two most common concentrations from compounding pharmacies are 1 mg/mL (with 0.5 mg/mL cyanocobalamin) and 5 mg/mL (with 0.5 mg/mL cyanocobalamin)

The key difference is the route of administration and approved doses
