Determination That Alcohol and Dextrose Injection, 5 Milliliters/100 Milliliters, 5 Grams/100 Milliliters; and 10 Milliliters/100 Milliliters, 5 Grams/100 Milliliters, Were Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Issuing agencies
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that Alcohol and Dextrose Injection, 5 milliliters (mL)/100 mL, 5 gram (g)/100 mL; and Alcohol and Dextrose Injection, 10 mL/100 mL, 5 g/100 mL, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for Alcohol and Dextrose Injection, 5 mL/100 mL, 5 g/100 mL; and 10 mL/100 mL, 5 g/100 mL.
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